Gastrostomy catheter - University of Groningenscripties.umcg.eldoc.ub.rug.nl/.../PruijsenJM.docx · Web viewIn a multivariate logistic regression model the major risk factors for

Fluoroscopy prior to gastrostomy tube insertion predicts success of percutaneous endoscopic procedure in high-risk children.

Student: Jessica Pruijsen

Student number: 1493817

Supervisor: P.F.van Rheenen

Location: University Medical Center Groningen

Department: Pediatrics, Gastroenterology

Period: March 2011 – July 2011

Abstract

Background:

Percutaneous endoscopic gastrostomy (PEG) tube placement has been shown to be a safe and effective procedure for children with feeding problems who need long-term tube feeding. In our hospital PEG insertions are performed in the endoscopy unit under general anaesthesia. In case of unexpected failure of endoscopic insertion, the child needs to be rescheduled for a surgical procedure in the operating room. We evaluated the efficiency of using fluoroscopy in the preparatory phase to predict the success of the percutaneous endoscopic procedure and avoid rescheduling.

Methods:

We performed a single center cohort study in a tertiary care hospital in the Netherlands. Eligible patients were identified from our gastrostomy care registry and had their tubes inserted between January 2000 and December 2010. They were included in the analysis when fluoroscopy was performed in the preparatory phase prior to tube insertion. Fluoroscopy was considered normal when the stomach projected distal to the costal margin. Primary endpoint was the success rate of PEG insertion. Multivariate logistic regression analysis was used to identify factors associated with PEG insertion failure.

Results:

We included 303 children (age range 0.3 to 18.1 years) and PEG tube insertion was successful in 287 (95%). Probability of success after normal fluoroscopy was 97% (95% confidence interval 95 to 99%), and after abnormal fluoroscopy 64% (9%% CI 53 to 84%). In a multivariate logistic regression model the major risk factors for PEG insertion failure were previous abdominal surgery (Odds ratio 7.7 [95% CI 1.9 to 31.4]), abnormal vertebral and gastric anatomy (OR 7.3 [(95% CI 1.6 to 34.5]), neurological impairment (OR 4.4 [95% CI 1.2 to 16.3]) and abnormal fluoroscopy (OR 17.6 [95% CI 4.7 to 65.8]), The probability of successful PEG tube insertion in high-risk children with an abnormal fluoroscopy was 50% (95% CI 25% to 75%).

Conclusion:

The strategy of performing fluoroscopy in high-risk children enables the endoscopist to identify those that should primarily undergo surgical gastrostomy placement.

Key words: PEG, fluoroscopy, success rate.

Abbreviations: PEG: percutaneous endoscopic gastrostomy.

Table of contents

Abstract2

Introduction4

Gastrostomy catheter4

Indications5

Contra-indications5

Preparations prior to insertion5

Technique of insertion5

Post-insertion6

Success rate6

Aim of the study7

Materials and methods8

Study design8

Patients8

Data collection8

Definitions of variables8

Underlying clinical condition8

Fluoroscopy8

Insertion of gastrostomy-catheter9

Replacement with skin level device (Button gastrostomy tube)9

Mortality9

Outcome10

Statistical analysis10

Ethical approval and informed consent10

Results11

Patient selection11

Fluoroscopy12

Logistic regression analysis13

Risk factors13

Scenario analysis15

Replacement with skin level device17

Mortality18

Discussion19

Key results19

Limitations of our study20

Interpretation20

Generalizability21

Acknowledgements21

References22

Samenvatting25

Appendix I: Questionnaire in other hospitals in the Netherlands and results

Appendix II: Case report file

Appendix III: Underlying clinical conditions

Introduction

Children with feeding problems may need long-term tube feeding, as long as their gastrointestinal tract is able to tolerate enteral nutrition.1 If not, then parenteral (intra-venous) nutrition is indicated.

Short-term tube feeding (up to three months) can be given through the nasogastric, nasoduodenal, or nasojejunal route. In case of a gastric emptying disorder the latter two options are preferred. For patients who require more than three months of tube feeding a gastrostomy catheter may be inserted.2

Gastrostomy catheter

In 1979 Gauderer, Ponsky and Izant introduced the percutaneous endoscopic gastrostomy (PEG) catheter. Before that time the gastrostomy catheter was placed using an open surgical procedure (open gastrostomy).3 In the past decades PEG placement has become a well-accepted procedure. PEG can be inserted by the push (Sachs-Vine), pull (Ponksy), introducer (Russell) and Versa (t-fastener) technique. The most widely used method is the pull through method which is the most safe and effective way to insert a PEG tube nowadays.4,5

Figure 1: Options for insertion of gastric enteral feeding tubes.

Nowadays the gastrostomy catheter placement can also be assisted by other methods including laparoscopy, ultrasonography and fluoroscopy.2,6 Figure 1 shows the indications and techniques of gastric feeding tube insertion in children.

Indications

In the early days the majority of gastrostomies were placed during neonatal surgery.4,7 Nowadays the largest group of children has a neurological impairment, with cerebral palsy being the most frequent neurological condition.7-10 Other common underlying diseases include metabolic disorders, cystic fibrosis, chronic renal disease, craniofacial abnormalities and cardiac heart disease.8,11,12 In 22% of cases there is no specific underlying condition.11

Contra-indications

Absolute contra-indications for PEG tube insertion include coagulation disorders (defined as an international normalized ratio > 1.5; a partial thromboplastin time > 50 seconds; or a platelets count < 50.000/mm3). Other absolute contra-indications are interposition of abdominal organs, severe ascites, peritonitis, pharyngeal or esophageal obstruction, gastric varices and an unstable clinical condition of the child.6 Because of size restrictions and safety the weight of the child needs to be at least 2.3 kg at the time of insertion.6,13

Preparations prior to insertion

Prior to insertion a carefully history must be taken which may include a physical examination and nutritional assessment. In most cases a nasogastric tube is already in situ which needs to be replaced by the PEG catheter. In children who were not yet tube fed prior to introduction of PEG, a two weeks trial of nasogastric tube feeding may be done first.14 Fasting time before the procedure should be at least six hours.15,16

Technique of insertion

The pull through method is performed in an endoscopy unit or operating theatre under sterile surgical conditions. In children general anaesthesia is used.6,16 During this procedure a gastrostomy catheter will be placed into the stomach through the skin and abdominal wall by endoscopy guidance. The procedure is performed by two physicians. The endoscopist will insufflate air in the stomach through the scope while the other physician will identify the place of insertion by finger impression and transillumination. The impression should be visible with the endoscope. Transillumination (diaphanoscopy) is a method which passes light through the skin to detect a direct pathway for insertion. If finger indentation or transillumination is not possible interposition of organs is likely.17

The tract identified by these two actions will be tested for the presence of interposition of other organs by using a needle with syringe. If air bubbles are present in the syringe the trocar must be removed and repositioned to an alternative site, or the procedure should be converted to an open gastrostomy procedure. If the test succeeds, a small incision will be made into the anterior abdominal wall at the site of the identified location (Figure 2a, 2b). A wire will be introduced through the incision into the stomach, snared and withdrawn orally (Figure 2c, 2d). The PEG catheter will be attached to the guide wire and by pulling the wire the catheter slides down the oropharynx, esophagus and stomach to reach the outside world again through the abdominal wall. An internal bumper located at the end of the catheter secures the position of the catheter and prevent migration through the gastric wall. On the skin, an external bumper prevents that the catheter drops back into the stomach (Figure 2e, 2f, 3).17

In most cases feeding can be started six hours after insertion.17 Generally a tube with a large lumen is used, as smaller sizes have a higher probability of obstuction.6 Currently PEG tube systems are made of polyurethane or silicone rubber and a wide variety of dietary and nutritional preparations are available for this type of nutritional support.6

Figure 3: Position of PEG catheter

The PEG catheter in situ after insertion

into the gastric wall.

Figure 2: Technique of PEG placement. Image (b),

(c) and (e) are made inside the stomach of the

patient with the endoscope.

Post-insertion

The tubing material deteriorates over time and should be replaced by a flush button gastrostomy if indicated.18 This procedure should not be considered before the seal between the stomach and abdominal wall is formed (approximately eight to twelve weeks after PEG insertion) to avoid soiling to the peritoneal cavity.19 Buttons contain an anti-reflux valve that prevents skin lesions.20 The flush buttons should be replaced every three months.6 Flush buttons are less cost-effective in comparison with catheters and are frequently used for cosmetic reason.6

Success rate

The endoscopic gastrostomy method introduced by Gauderer is beneficial in comparison to the open gastrostomy procedure, because the method has proven to be less invasive, quicker and more cost-effective.17 Morbidity and mortality are not significantly different.21

Success rate of procedure ranges between 95-98%.12,18,22-24 Failure occurs if inadequate gastric indentation and transillumination is established. If insertion fails the child needs to be rescheduled for a procedure in the operating room.18

For logistic reasons it would be ideal to estimate the risk of failure before planning the procedure. Fluoroscopy may be used in the preparatory phase to estimate the risk of conversion to a surgical procedure. By fluoroscopy the position of the stomach in relation to the costal margin can be assessed, eventually after air insufflation into the stomach.2 In case the stomach is not visible below the costal margin it will be difficult to insert the PEG catheter at an appropriate location.18 In this case the physician may decide to use a different planning strategy or a different insertion technique. The ultimate goal is to avoid a second general anaesthesia.

The use of fluoroscopy in the preparatory phase is not generally accepted in the Netherlands. The results of an inventory questionnaire that was distributed among Dutch pediatric gastroenterologists in April 2011 showed lack of uniformity in strategy

(Appendix I). We received response from 12 hospitals with a pediatric GI specialist. In three out of 12 hospitals fluoroscopy was never performed, in five fluoroscopy was only performed when anatomic abnormalities were expected, and in the remaining four fluoroscopy was performed routinely in all children. In one hospital all gastrostomies were placed by surgeons instead of endoscopists.

Aim of the study

The value of fluoroscopy to identify patients with an increased risk of endoscopic failure has never been evaluated. We aim to evaluate the value of fluoroscopy in the preparatory phase to predict successful endoscopic gastrostomy insertion and avoid rescheduling.

Materials and methods Study design

We performed a single center cohort study in the Beatrix Children’s Hospital – University Medical Center Groningen, a tertiary care university teaching hospital in the Netherlands.

Patients

Eligible patients were identified from four different hospital registries: (1) surgical procedures registry; (2) hospital admission registry; (3) endoscopy center registry; (4) outpatient department registry. By combining these registries we are confident to have included all children that underwent gastrostomy placement between January 2000 and December 2010. Duplicate records were manually deleted and the required information from patient files was entered in a predesigned computerized database. Exclusion criteria were age above 18 years at the time of indication for gastrostomy insertion, gastrostomy placement not performed in UMCG, other procedures of insertion, non-conclusive fluoroscopies and insufficient data. All patients were managed according to the dictates of their physicians, and not by standardized protocols.

Data collection

Data retrieved from the electronic patient files included age, sex, age at gastrostomy insertion, indication for placement and underlying clinical diagnosis, use of fluoroscopy, antibiotic prophylaxis, type of procedure used for gastrostomy placement, need to conversion, time until button placement and survival. Patients were followed until death, permanent removal of the gastrostomy catheter, transition to adult care, or March 1st 2011 (end of follow-up). Data collection was done between March and April 2011 by a single investigator (JP).

Definitions of variablesUnderlying clinical condition

The group of neuromuscular disorders included children with motor impairment, cerebral palsy or developmental delay. Children were classified into the group of metabolic disorders when blood analyses had confirmed an inborn error of metabolism. Children were classified into the group of syndromic disorders when they had multiple malformations with a single etiology.25 Other etiologies included malignancies, cystic fibrosis, congenital heart disease, chronic renal disease, gastrointestinal disease and failure to thrive of unknown origin. The remaining conditions were pooled in the group “miscellaneous”.

Fluoroscopy

Imaging studies were included in the analysis when requested by the gastroenterologist in the preparatory phase with a maximum interval of 6 months until gastrostomy placement. Fluoroscopy was considered normal when the stomach projected distal to the costal margin. When the stomach remained behind the rib cage despite air insufflation through a nasogastric tube, the fluoroscopy was considered abnormal (Figure 4). When the radiology report was ambiguous the patient was excluded from the final analysis.

Figure 4: Abnormal fluoroscopy. The white lines mark the distal costal margin. After insufflation of air through the nasogastric tube the stomach position remained unchanged behind the rib cage.

Insertion of gastrostomy-catheter

In case percutaneous endoscopic gastrostomy placement failed, conversion to a surgical procedure was required. We reported if conversion was done during the same general anaesthesia (anticipated risk for conversion) or if rescheduling for the operating theatre was needed.

Replacement with skin level device (Button gastrostomy tube)

We recorded date and indication of replacement with a skin level device. In the absence of gastrostomy complications the reason for replacement was considered to be elective. If no replacement occurred at all, the reason was also recorded.

Mortality

Age at death and cause were reported.

Outcome

The primary outcome of this study was the success rate of PEG insertion and the need for rescheduling anaesthesia in case of failure. We aimed to identify risk factors for failure of the PEG procedure. Secondary outcomes included the need for a repeated session under general anaesthesia, time till button replacement and mortality rate.

Statistical analysis

Data were collected on standardized forms (Appendix II), and analyzed with SPSS for Windows (version 18.0 Chicago, IL). Student t tests and Chi-square tests were used to compare baseline characteristics between groups. For non-parametric data the Mann-Whitney U-test was used. All tests were two-tailed. A p-value < 0.05 was considered significant.

Stepwise logistic regression with backward elimination was used to analyze potential risk factors related to failure of PEG placement. Explanatory factors with a p-value < 0.10 in univariate analysis were kept in the final multivariate model. Effect size was expressed as odds ratio (OR) and 95% confidence interval (CI). We calculated the probability of successful PEG placement after having performed fluoroscopy alone, as well as after classifying patients as high-risk group with subsequent targeted fluoroscopy.

Ethical approval and informed consent

This study was exempted from Institutional Review Board approval as it involved the study

collection of data generated by routine medical care. The data were collected and recorded by the investigators in such a manner that subjects could not be identified, directly or through identifiers linked to the subjects.

ResultsPatient selection

A total of 410 children were eligible for inclusion. We excluded 107 patients (26%) because of predefined exclusion criteria (Figure 5). Table 1 shows characteristics of the 303 included patients, divided into two groups (normal and abnormal fluoroscopy result), as well as the characteristics of the excluded patients.

Figure 5: Study flow diagram.

Characteristics of children with normal and abnormal fluoroscopy did not differ significantly from those excluded from analysis. The children with normal and abnormal fluoroscopy were comparable in terms of age and gender distribution. Indication for PEG was in 99% of children prolonged tube feeding. In 25% of children dysphagia was an indication for placement. A total of 105 children had a neuromuscular disorder (33%) with cerebral palsy being the commonest condition (n=40). An overview of all clinical diagnoses is shown in Appendix III.

Table 1: Patient characteristics.

Normal fluoroscopy

Abnormal fluoroscopy

Excluded patients

N

281

22

107

Gender

Girls (%)

130 (46.3)

12 (54.5)

61 (52.1)

Age at percutaneous endoscopic gastrostomy insertion in years (median, range)

1.9

(0.34-17.40)

7.2

(0.85-18.11)

2.6**

(0.01-17.67)

Indication for percutaneous endoscopic gastrostomy insertion*(%)

Prolonged tube feeding

Dysphagia

Frequent aspiration

Insufficient caloric intake

Other

Unknown

278 (99)

70 (25)

6 (2)

4 (1)

17 (6)

0 (0)

22 (100)

7 (31)

0 (0)

2 (9)

1 (4)

0 (0)

109 (93)

12 (11)

2 (2)

4 (4)

6 (5)

2 (2)

Underlying clinical condition (%)

Neuromuscular disease

Metabolic disease

Congenital heart disease

Syndromic disorder

Failure to thrive of unknown origin

Other

93 (33)

39 (14)

21 (8)

67 (24)

19 (7)

42 (15)

12 (54)

5 (23)

0 (0)

0 (0)

1 (5)

4 (18)

40 (37)

9 (9)

1 (1)

16 (15)

4 (4)

37 (35)

*The total was more than 100% because multiple reasons for placement could be indicated.

** For this result only 57 patients could be used.

Fluoroscopy

PEG tube insertion was successful in 287 (95%) of all children, of them 273 had a normal and 14 an abnormal fluoroscopy. PEG catheter insertion failed in sixteen children, and in eight of them the fluoroscopy result was abnormal. Only eight of the sixteen children were already planned on the operating room.

The prior probability of success of insertion is 287/303, with a positive likelihood ratio of 1.9 (95% confidence interval 1.6 to 3.1) and a negative likelihood of 0.1 (95% confidence interval 0.05 to 0.20). After a normal fluoroscopy the probability of successful PEG-placement increased to 97% (95% confidence interval 95 to 99%), and after abnormal fluoroscopy the probability of success was reduced to 64% (95% confidence interval 53 to 84%). This is shown in a Fagan nomogram in Figure 6.

Normal fluoroscopy


Figure 6: Fagan nomogram. Probability of success before and after fluoroscopy.

Prob= probability

Logistic regression analysis

Potential risk factors for failure of PEG insertion included age, sex, underlying clinical condition, previous abdominal surgery and abnormal vertebral and gastric anatomy. In univariate analysis, as shown in Table 2, abnormal fluoroscopy, neurological impairment, previous abdominal surgery and abnormal vertebral and gastric anatomy were significantly associated with need of conversion. In multivariate analysis all four explanatory parameters remained statistically significant.

Risk factors

A total of 123 children were classified as high-risk patients. Table 3 contains all previous abdominal surgeries that were performed prior to the gastrostomy insertion and all vertebral and gastric anatomic abnormalities that have been objectified before the endoscopic procedure.

Table 2: Logistic regression analysis.

Dependent

Analysis

Explanatory variables

Regression coefficient

Odds ratio

[95% CI]

P-value

Conversion required

Univariate

Girls

-0.133

0.9

[0.3-2.4]

0.798


2.970

19.50

[6.38-59.62]

0.000

Neurological impairment

1.834

6.26

[1.97-19.93]

0.002

Metabolic disease

-0.944

0.4

[0.05-3.04]

0.367

Syndromic disorder

-0.718

0.5

[0.1-2.2]

0.351

Previous abdominal surgery

1.652

5.22

[1.68-16.3]

0.005

Abnormal vertebral and gastric anatomy

2.533

12.59

[3.67-43.12]

0.000

Conversion required

Multivariate


2.865

17.55

[4.68-65.83]

0.000


2.047

7.74

[1.91-31.43]

0.004


1.474

4.37

[1.17-16.3]

0.017


2.006

7.32

[1.6-34.47]

0.010

Table 3: Previous abdominal surgery and abnormal vertebral and gastric anatomy.



Ventriculoperitoneal drain insertion

11

Scoliosis

8

Intestinal surgery

7

Abnormal position of stomach

3

Gastroschisis

2

Trans-esophageal stenosis

2

Diagnostic laparotomy

2

Substantial lordosis

1

Adrenal resections

2

Congenital micro stomach

1

Nephrectomy

1

Patch insertion

1

Peritoneal catheter insertion

1

Relaparotomy of omentum prolapse

1

Total

28

15

Scenario analysis

During the study period between 2000 and 2010 fluoroscopy was requested in all children (n=303). The success rate in children with a normal fluoroscopy (n=281) was 97% (95% CI 95 to 99%), while eight children from this group needed rescheduling on an operating room (Table 4). The success rate in the group with abnormal fluoroscopy (n= 22) was 64% (95% CI 53 to 84%), with conversion to surgery being possible in the same anaesthesia session for eight children.

If a physician would schedule all children belonging to a high-risk group (41%, 123/303) for the operating room, probability of success in the low-risk group would be 99%

(95% CI 98 to 100%) and one child would need rescheduling. Probability of success in the high-risk group would be 89% (95% CI 82 to 94%), with conversion to surgery being possible in the same anaesthesia session for fourteen children.

In the scenario where only high-risk children are subjected to fluoroscopy and the children with abnormal fluoroscopy are scheduled on the operating room, probability for success with normal fluoroscopy would be 94%. In this scenario eight children would need rescheduling, one low-risk child and seven high-risk children with normal fluoroscopy. The success rate in the group children with abnormal fluoroscopy would be 50%, with conversion to surgery being possible in the same anaesthesia session for eight children.

Table 4: Scenario analysis

Variable

Patients, n

PEG insertion succeeded, n

Proportion of patients

[95% confidence interval]

Fluoroscopy

Normal

281

273

97[95 -99]

Abnormal

22

14

64 [53-84]

Risk factors

Absent

179

178

99[98-100]

Present

124

109

89 [83-94]

Risk factors present AND

Fluoroscopy normal

108

101

94 {89-99]

Fluoroscopy abnormal

16

8

50 [25-75]

False negatives

Fluoroscopy prior to gastrostomy tube insertion predicts success of PEG procedure in high-risk children. J.M.Pruijsen.

In the third scenario, eight patients would be false negative. Characteristics of these patients are shown in Table 5. Marked is the only low-risk patient.

2

Page | 2

Table 5: False negative children after scenario analysis.

Sex

Age (years)

Underlying clinical condition

Risk factors present

Reason of failure

Proceeded on OR

Same general anaesthesia

Boy

3.8

Neuromuscular disorder (Congenital myopathy)

Yes; neurological impairment, scoliosis

Insufficient direct impression possible

No

No

Boy

3.7

Neuromuscular disorder (Infantile encephalopathy)

Yes; neurological impairment and previous abdominal surgery


Yes

Yes

Girl

1.6

Syndromic disorder (Syndrome of Goldenhar)

Yes; previous abdominal surgery


Yes

No; other procedure scheduled on the same time

Girl

1.3

Neuromuscular disorder (Congenital hydrocephalus)



No

No

Boy

3.4

Neuromuscular disorder (Status following neonatal meningitis)

Yes; neurological impairment


Yes

No; unknown

Boy

1.3

Neuromuscular disorder (Periventricular leucomalacia)

Yes; neurological impairment


No

No

Boy

12.3

Neuromuscular disorder (Severe PMR)



No

No

Boy

3.8

Syndromic disorder (VACTERL association)

No


No

No

OR = operation room; PMR = psychomotor retardation; VACTERL = Vertebral anomalies, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal (kidney) and/or radial anomalies, Limb defects.

22

Page| 17

Replacement with skin level device

A total of 250 out of 287 PEG tubes were replaced by skin level devices after a median delay of 4.1 months (range 0.2-24.6 months). Figure 7 shows the proportion of children with replacement in time. In the majority of cases (93%) this replacement was an elective procedure. Other reasons for replacement included leakage (3%), obstructed tube (2%) and tube dislodgement (1%). In one occasion the gastrostomy catheter was exchanged for a jejunal tube inserted through the gastrostomy, with the tip positioned distal to the ligament of Treitz.

Six children were lost to follow-up. In the remaining 31 children replacement with a skin level device was not done because of death (9), replacement by another type of tube (PEG balloon (13), gastrostomy was no longer needed (3), or the child was still waiting for the replacement procedure (6).

Figure 7: Proportion of children with replacement of gastrostomy catheter by skin level device in time.

Mortality

Of the 303 children with intended PEG insertion 56 (18.5%) died because of the underlying clinical condition, no significant difference between conversion group and group children with realization of PEG. No child died because of the PEG procedure itself. Median age at death was 4.4 years (range 0.9-21.2 years), with a median period of 19.7 months (range 0.8-102.8 months) after PEG insertion. Of the deceased children 23 were suffering from neuromuscular disorder, 10 of metabolic disorder, 9 of a syndromic disorder, 3 of congenital heart disease and 11 of another underlying clinical conditions (of which 45 % died because of malignancy) (Figure 8).

Figure 8: Causes of mortality after PEG insertion.

DiscussionKey results

PEG placement is the preferred technique for enteral access in patients with longstanding insufficient oral intake.5,26 The procedure is safe8,26 , but failure of PEG insertion and consequently rescheduling of the procedure on the operating room is frustrating for the child, the parents and the physicians.4,18 We aimed to evaluate the value of fluoroscopy in the preparatory phase to predict successful endoscopic gastrostomy insertion and avoid rescheduling. We also aimed to identify risk factors for failure of the PEG procedure.

We report in this large single center cohort study an overall success rate of PEG insertion of 95%, which is comparable with other reports.12,18,22-24 In children with normal fluoroscopy success rate was 97% and after abnormal fluoroscopy 64%. In logistic regression analysis we found that neurological impairment, previous abdominal surgery, abnormal vertebral and gastric anatomy and abnormal fluoroscopy are significant predictors of failure of PEG insertion. When one of these risk factors is present a child belongs to the high-risk group. High-risk children with an abnormal fluoroscopy have a significantly reduced success rate for PEG placement.

To our knowledge this is the first prognostic study that identified predictors for success of PEG insertion, with fluoroscopy playing a key role in the preparatory phase. One study group of Taiwan used plain abdominal films with insufflation of 500 ml air in adults to determine a safe gastric puncture point before percutaneous endoscopic gastrostomy.27 PEG placement was then performed one day after fluoroscopy. Even in patients with expected puncture points proximal to the costal margin PEG placement was performed without anticipating a potential switch to a surgical procedure. In one patient (1.2%) the procedure failed as the stomach was located under the rib cage.

Another group studied adult patients who had a PEG insertion failure or who were unsuitable for PEG.28 These patients were referred to the radiology department for fluoroscopic gastrostomy insertion. Among a group of 22 patients with previous PEG insertion failure (inadequate transillumination), 16 had abnormal fluoroscopy with the stomach high above the costal margin.

A group from the UK recently published their single center experience with PEG placement. In 384 insertions conversion to surgery was needed in eight (2%). In 4 cases this was due to an abnormal position of the stomach in children with cerebral palsy, two cases had a scarred abdomen.12

Despite earlier reports indicating that PEG insertion could be safely and effectively performed after previous laparotomy, we found that previous abdominal surgery is a predictor for PEG failure.29 One study found that abdominal surgery did not negatively influence the success rate of the procedure.30 They had a success rate of 97% versus 82% (23/28) in our study.

Limitations of our study

The limitations relate to the retrospective nature of this study. We could have introduced a selection bias as some patients with abnormal fluoroscopy were preventively scheduled for a surgical gastrostomy procedure. These patients were not included in our analysis.

The persons who reviewed the fluoroscopies were not blinded for the underlying condition of the child. This may have caused a bias, as the evaluation of fluoroscopy is a relatively soft measure. Knowing that a child belongs to high-risk group may have caused the assessor to judge a certain configuration of the stomach bubble more negatively.

Interpretation

In the UMCG, until now all children with a need for gastrostomy underwent fluoroscopy in the preparatory phase of PEG. In case of abnormal fluoroscopy children were scheduled for the procedure on the operating room. Eight children with normal fluoroscopy will be missed, which means that they need to be rescheduled for a surgical procedure. With this strategy the majority of children is exposed to radiation unnecessary. With the new strategy, performing fluoroscopy only in high-risk children and scheduling children with abnormal fluoroscopy on the operating room directly, the number of fluoroscopies will be reduced with 59%, while still eight children would need rescheduling on the operating room. In other words, the number of fluoroscopies would be reduced dramatically, while the number of reschedulings will not increase.

Low-risk children have a high success rate for PEG insertion (99%), and 1% of missed cases for whom rescheduling is necessary is acceptable. All low-risk children should be planned on the endoscopy unit, unless scheduling on the operation room is indicated for anaesthetic

reasons.

High-risk children do not only have a high risk for PEG failure, but at the same time they also have more risk during anaesthesia.7,31 Most of these children have a neurological impairment and a poor nutritional status.10 Rescheduling for another procedure under general anaesthesia is undesirable. This, as well the fact of poor condition, makes it desirable to avoid rescheduling.

In children who appear unsuitable for PEG placement after fluoroscopy, the other insertion options need to be carefully weighed. In the past, open surgical procedure was first choice in these children. In the latest decennia percutaneous radiological insertion, laparoscopic assisted percutaneous endoscopic gastrostomy and laparoscopic gastrostomy have become well accepted alternatives.28,32,33

In case the new strategy is adopted in the UMCG, high-risk children with abnormal fluoroscopy will be scheduled on the operating room. The endoscopist will start the procedure and if PEG placement fails, the surgeon standing by will convert to an open procedure. This collaboration is beneficial for the child, as insertion of the gastrostomy catheter can always be guaranteed during the same anaesthesia.

Generalizability

In most pediatric centers, like Beatrix Children’s Hospital – UMCG, the percutaneous endoscopic gastrostomy catheter is usually placed by a pediatric gastroenterologist. Commonly the PEG indicated is in neurologically impaired children. In conclusion, the physician, procedure and target group for PEG insertion are generally identical in different pediatric hospitals, so the results of our single center experience should be suitable for use in other settings.

Our prediction model is of little clinical value, unless it is shown to perform well for other patient cohorts. We therefore advise the UMCG to implement the new screening strategy, but at the same time to monitor future success rate of PEG insertions.

Acknowledgements

The author would like to thank nurses Anneke Bruin and Greetje Sekema for providing their patient registry, advises and illustrations. Further thanks to Esther Poele for practical information about PEG. Many thanks to my supervisor Patrick van Rheenen for his critical view and guidance with this research.

References

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(2) Nijs EL, Cahill AM. Pediatric enteric feeding techniques: insertion, maintenance, and management of problems. Cardiovasc Intervent Radiol 2010;33:1101-1110.

(3) Gauderer MW, Ponsky JL, Izant RJ,Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg 1980;15:872-875.

(4) Gauderer MW. Percutaneous endoscopic gastrostomy: a 10-year experience with 220 children. J Pediatr Surg 1991;26:288-294.

(5) Gauderer MW. Percutaneous endoscopic gastrostomy and the evolution of contemporary long-term enteral access. Clin Nutr 2002;21:103-110.

(6) Löser C, Aschl G, Hébuterne X, Mathus-Vliegen EM, Muscaritoli M, Niv Y, et al. ESPEN guidelines on artificial enteral nutrition--percutaneous endoscopic gastrostomy (PEG). Clin Nutr 2005;24:848-861.

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(9) Fröhlich T, Richter M, Carbon R, Barth B, Köhler H. Review article: percutaneous endoscopic gastrostomy in infants and children. Aliment Pharmacol Ther 2010;31:788-801.

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Samenvatting

Achtergrond:

Het is gebleken dat de percutane endoscopische gastrostomie plaatsing een veilige en effectieve procedure is in kinderen die voedingsproblemen hebben met daarbij langdurige behoefte aan enterale voeding. In ons ziekenhuis worden PEG plaatsingen onder algehele narcose uitgevoerd op het endoscopiecentrum. Indien onverwacht het plaatsen van een PEG niet lukt, zal het kind tijdens een nieuwe procedure een chirurgische gastrostomiekatheter op de operatiekamer moeten krijgen. Wij hebben geëvalueerd of het gebruik van fluoroscopie in de voorbereidingsfase van de PEG plaatsing effectief is om het succes van de plaatsing te voorspellen evenals het vermijden van een tweede narcose.

Methoden:

We hebben een single cohort studie uitgevoerd in een tertiair ziekenhuis in Nederland. Geschikte patiënten werden geïdentificeerd uit ons gastrostomie-registratiesysteem waarbij alle patiënten hun gastrostomiekatheter hebben gekregen tussen januari 2000 en december 2010. Patiënten werden geïncludeerd als zij voor de plaatsing van de gastrostomiekatheter een fluoroscopie hadden gehad. Fluoroscopie werd als normaal beschouwd indien de maag distaal van de ribbenboog was geprojecteerd. De primaire uitkomstmaat was de kans op succes van de PEG insertie. Multivariate logistische regressie analyses werden gebruikt om factoren te identificeren die geassocieerd zijn met het falen van de PEG procedure.

Resultaten:

In de studie werden 303 kinderen geïncludeerd (leeftijd tussen de 0.3 en 18.1 jaar) waarbij de PEG procedure in 287 kinderen (95%) succesvol was. De kans op een succesvolle procedure na een normale fluoroscopie was 97% (95% CI 95 tot 99%) en na een abnormale fluoroscopie 64% (95% CI 53 tot 84%). Na multivariate logistische regressie analyse zijn de volgende factoren geassocieerd met het falen van de PEG insertie: abdominale chirurgie in de voorgeschiedenis (Odds ratio 7.7 [95% betrouwbaarheidsinterval 1.9 tot 31.4]), anatomische afwijkingen van de wervelkolom en maag (OR 7.3 [95% CI 1.6 tot 34.5]), neurologische schade (OR 4.4 [95% CI 1.2 tot 16.3]) en abnormale fluoroscopie (OR 17.6 [95% CI 4.7 tot 65.8]). De kans op een succesvolle PEG insertie in hoogrisico kinderen en abnormale fluoroscopie was 50% (95% CI 25% tot 75%).

Conclusie:

De strategie van het uitvoeren van fluoroscopie in hoogrisico kinderen zorgt ervoor dat de endoscopist die patiënten kan identificeren die direct voor een chirurgische gastrostomie plaatsing in aanmerking moeten komen.

Trefwoorden: PEG, fluoroscopie, slagingskans

Afkortingen: PEG: percutane endoscopische gastrostomie.

24

Appendix I: Questionnaire in other hospitals in the Netherlands and results.

PEG studie

Geachte heer/mevrouw,

Momenteel doe ik wetenschappelijk onderzoek bij de kinder-MDL in het UMCG naar de percutane endoscopie gastrostomiekatheter (PEG katheter). In het UMCG wordt voorafgaand aan de plaatsing van deze gastrostomie katheter een maagdoorlichtingsfoto gemaakt om te zien of de maag goed onder de onderste ribben ligt, wat voorspellend zou zijn voor het welslagen van de ingreep. Indien dit niet het geval is kan vooraf besloten worden om de procedure op OK te laten plaatsvinden, zodat een eventuele conversie naar een chirurgische procedure tijdens dezelfde narcose kan gebeuren. De onderzoeksvraag van mijn onderzoek is: Leidt het vooraf maken van een maagdoorlichtingsfoto tot een vermindering van het aantal mislukte PEG plaatsingen en narcoses?

Ik vroeg mij af of er in andere kinder-MDL centra ook een maagdoorlichtingsfoto wordt gemaakt voorafgaand aan de procedure. Ik hoop dat u een klein aantal vragen voor mij zou willen beantwoorden zodat ik een inventarisatie kan maken wat er landelijk gedaan wordt.

Hartelijk bedankt voor uw medewerking.

Vriendelijke groet,

namens dr. P.F van Rheenen.

Jessica Pruijsen

--------------------------------------------------------------------------------

1. In welk kinder-MDL centrum werkt u?

2. Wordt er in uw centrum een maagdoorlichtingsfoto gemaakt voorafgaand aan de PEG katheter

plaatsing?

· Ja

· Nee

Indien uw antwoord nee is, kunt u de enquête afsluiten en versturen.

3. Laat u standaard bij ieder kind dat komt voor een PEG-plaatsing een maagdoorlichtingsfoto

maken?

· Ja

· Nee

Indien uw antwoord ja is, kunt u de enquête afsluiten en versturen.

4. Voor welke indicatie laat u wel een maagdoorlichtingsfoto maken?

· Een intra-abdominale operatie in de voorgeschiedenis

· Te verwachten anatomie afwijkingen bij het kind

· Anders, namelijk………………………………………………..

U kunt de enquête afsluiten en versturen.

Table 6 : Responses of questionnaire

In welk kinder-MDL centrum werkt u?

Wordt er in uw centrum een maagdoorlichtings-foto gemaakt voorafgaand aan de PEG-katheter plaatsing?

Laat u standaard bij ieder kind dat komt voor een PEG-plaatsing een maagdoorlichtingsfoto maken?

Voor welke indicatie laat u wel een maagdoorlichtingsfoto maken?

Opmerkingen

Amsterdams Medisch Centrum

Nee

Vrije Universiteit medisch centrum Amsterdam

Ja

Nee

Te verwachten anatomie afwijkingen, verdenking afwijkende maaglediging.

Universitair Ziekenhuis Antwerpen

Ja

Nee

Te verwachten anatomie afwijkingen

Wilhelmina ziekenhuis, Assen

Ja

Ja

Jeroen Bosch Ziekenhuis, Den Bosch

Ja

Ja

Juliana Kinderziekenhuis, Den Haag

Ja

Ja

Medisch Spectrum Twente, Enschede

Nee

Universitair Medisch Centrum Groningen

Ja

Ja

Isala klinieken Zwolle

Ja

Nee


Leids Universitair Medisch Centrum

Ja

Nee


Erasmus Medisch Cebtrum, Sophia kinderziekenhuis, Rotterdam

Ja

Nee


In kinderen met abdominale chirurgie in de voorgeschiedenis of een VP drain wordt een laparoscopische geassisteerde PEG procedure uitgevoerd.

Utrechts Medisch Centrum

Nee

PEG wordt aangelegd door chirurg.

MDL = Maag-, Darm-, Lever-,. PEG = Percutane endoscopische gastrostomie. VP= ventriculo-peritoneale .

Appendix II: Case report file

PEG Study

Patient information

Personal identification-nr|_|_|_|

UMCG-nr|_|_|_||_|_|_||_|

Sex|_| Boy

|_| Girl

Date of birth|_|_| - |_|_| - |_|_||_|_|

Preliminary phase

Date of PEG insertion |_||_|-|_||_|-|_||_||_||_|

Indications for PEG insertion|_| Prolonged NGT tube feeding

(more options possible)|_| Dysphagia

|_| Frequent aspiration

|_| Insufficient caloric intake

|_| Other

Underlying clinical condition|_| Neuromuscular disorder

One option possible|_| Metabolic disease

|_| Malignancy

|_| Cystic Fibrosis

|_| Chronic renal disease

|_| Craniofacial abnormalities

|_| Congenital heart disease

|_| Gastrointestinal disorder

|_| Syndromic disorder

|_| Failure to thrive of unknown origin

|_| Miscellaneous

Did the child have previous abdominal |_| Yes

surgery?|_| No

Did the child have abnormal anatomy?|_| Yes

|_| No

Procedure

Fluoroscopy|_| Yes

|_| No

If yes: was the stomach below costal|_| Yes

margin?|_| No

If no: did the procedure take place|_| Yes

in the operational theatre?|_| No

Kind of procedure|_| Pull through (Endoscopy)

|_| Push through (Radiology)

|_| Surgery (Open or laparoscopic)

If pull through, was procedure performed |_| Yes

on the operating room?|_| No

If yes, what was the indication?|_| Previous abdominal operation(s)

|_| Abnormal fluoroscopy

|_| Anaesthesia

|_| Other procedure at the same time

When initially pull or push through, was |_| Yes

conversion to surgical procedure required?|_| No

Follow-up

Date of hospital discharge after PEG insertion|_||_|-|_||_|-|_||_||_||_|

Did the follow-up take place|_| Yes

in the UMCG?|_| No

Button replcament

Date of button placement|_||_|-|_||_|-|_||_||_||_|

Indications of button placement|_|Elective switch to button

|_|Leakage

|_|Obstructed tube

|_|Tube dislodgement

|_|Other

Leakage

Death

Did the child die due to the |_| Yes

underlying condition?|_| No

Date of death|_||_|-|_||_|-|_||_||_||_|

NGT= nasogastric tube

Remarks:

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Appendix III: Underlying clinical conditions

Table 7: Underlying clinical conditions

Congenital heart disease

Metabolic disease

Cardiomyopathy

1

Amino acid metabolism abnormality

3

Coarctatio aortae

3

Alexander disease

1

Complex heart defects

9

CDG

4

Hypoplastic left heart syndrome

1

Glutaric acidemia

2

Tetralogy of Fallot

2

Glycogen storage disease

3

Transposition of the great vessels

2

Homocystinurie

2

Ventricular septum defect

3

Lysosomal disease

6

MADD

1

Craniofacial abnormalities

Menkes disease

1

Congenital hemangiomas

1

Mitochondrial disease

8

Palatoschisis

2

MTC-8 gen mutation (thyroid gland)

1

Retrognathia

2

Peroxisomal disease

4

PEX I deficiency

1

Gastrointestinal disorder

PKU

1

Autoimmune enteropathy

1

Pyruvate dehydrogenase complex deficiency

2

Congenital micro stomach

1

Ureum cyclus deficiency

3

Esophageal atresia

2

Spielmeyer-Vogt syndrome

1

Gastroschisis

1

Hirschsprung disease

1

Muscular disorder

Microvillus inclusion disease

1

Congenital myasthenic syndrome

1

Motility disorder

1

Duchenne muscular dystrophy

1

Proton pump deficiency

1

Dystony

1

Protein losing enteropathy

1

Myopathy

3

Trauma of esophagus

1

Spinal muscular atrofy

2

Unknown etiology

2

Lung problems

Bronchopulmonary disease

2


Chronic lung disease

11

Cerebral palsy

40

Cystic Fibrosis

3

Status following neonatal meningitis

1

Congenital cytomegalovirus

8

Malignancy

Damage after hypoxic event

3

ALL

1

Hemorrhage

3

Anaplastic ependymoma

1

Holoprosencephaly

2

Medullablastoma

3

Hydrocephalus

7

Nasopharynx carcinoma

1

Lisencephaly

1

Neuroblastoma

3

Microcephaly

8

Opticus glioma

1

Mitochondrial encephalopathia

1


Otakaza syndrome

1

Fetal alcohol syndrome

2

PML

2

Goldenhar syndrome

2

PMR

14

Microsyndroom

1

Rett syndrome

2

Noonan syndrome

1

West syndrome

1

PHACES association

1

Unknown etiology

1

Pierre Robin sequence

5

Rubinstein Taybi syndrome

1

Renal disorder

Rare chromosomal abnormalities

17

Fanconi syndrome

1

Silver Russell syndrome

1

Recurrent urinary tract infections

1

Townes Brocks syndrome

1

Resistent nephrotic syndrome

1

VACTERL association

1

Velo-cardio-facial syndrome

2

Syndromic disorder

Waardenburg syndrome

1

Apert syndrome

1

William Beuren syndrome

1

CHARGE association

4

Cockayne syndrome

1

Miscellaneous

Coffin Siris syndrome

1

Aerophagy

1

Cornelia de Lange syndrome

1

Eating disorders

18

Desbuquois like syndrome

1

Swallowing disorders

2

di George syndrome

1

Skeletdysplasy

1

Down syndrome

21

ALL= Acute Lymphoblastic Leukemia. CDG = Congenital Disorder of Glycosylation. MADD = multiple acyl-CoA dehydrogenation deficiency. MTC-8 gen mutation = Monocarboxylate Transporter-8 Mutation. Pex I deficiency = Peroxin 1 deficiency. PKU = Phenylketonuria. PML= Periventricular leukomalacia. PMR = Psychomotor retardation. PHACES = Posterior fossa abnormalities and other structural brain abnormalities, Hemangioma(s) of the cervical facial region, Arterial cerebrovascular anomalies, Cardiac defects, aortic coarctation and other aortic abnormalities, Eye Anomalies, Sternal defects and/or Supraumbilical raphe. VACTERL = Vertebral anomalies, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal (kidney) and/or radial anomalies, Limb defects.

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