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Click to edit Master subtitle style C S L C I E N N TREATMENT S E A R Search Terms: (PubMed) Percutaneous Cholecystostomy Versus Gallbladder Aspiration for Acute Cholecystitis: A Prospective Randomized Controlled Trial American Journal of Roentgenology 2004, July; 183(1):193-196 Kei Ito, Naotaka Fujita, Yutaka Noda, Go Kobayashi, Katsumi Kimura, Toshiki Sugawara, Jun Horaguchi Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi 983-0824, Japan. What intervention will best treat acute cholecystitis in patients at high risk for surgery? Population – high surgical risk patients Intervention – therapy Outcome – treatment of acute cholecytitis

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TREATMENT. What intervention will best treat acute cholecystitis in patients at high risk for surgery?. C S L C I E N N I A C R A I L O. Search Terms: (PubMed). Population – high surgical risk patients Intervention – therapy Outcome – treatment of acute cholecytitis. - PowerPoint PPT Presentation

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Click to edit Master subtitle style

C S

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TREATMENT

SEARCH

Search Terms: (PubMed)

Percutaneous Cholecystostomy Versus Gallbladder Aspiration forAcute Cholecystitis: A Prospective Randomized Controlled Trial

American Journal of Roentgenology 2004, July; 183(1):193-196Kei Ito, Naotaka Fujita, Yutaka Noda, Go Kobayashi, Katsumi Kimura, Toshiki Sugawara, Jun Horaguchi

Department of Gastroenterology, Sendai City Medical Center, 5-22-1, Tsurugaya, Miyagino-ku, Sendai, Miyagi 983-0824, Japan. 

What intervention will best treat acute cholecystitis in patients at high risk for surgery?

Population – high surgical risk patients

Intervention – therapy

Outcome – treatment of acute cholecytitis

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RELEVANCE

Is the objective of the article on harm similar to your clinical dilemma?

Yes. The population of the study includes institutionalized patients for acute cholecystitis.(Objective 3rd line. Subjects and methods lines 1-3 pg.193)

The study compared the effectiveness and incidence of complications of percutaneous cholecytectomy and gall bladder aspiration. (Objective lines 1 -3, pg 193).

Good clinical response was obtained in 27 patients (90%) of the percutaneous cholecystectomy group and in 14 patients (61%) of the gall bladder aspiration group (p<0.05) (Results lines 5 - 7 pg 193). There were no major complications or procedure- related deaths in either group.(Results last sentence pg 193) The overall complication rate of 3% in percutaneous cholecystostomy is low compared with previously reported rates of 4–24%(Discussion 4th paragraph lines 27-29 pg 195)

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VALIDITYGUIDES

Was it randomized? Was randomization concealed?

Was the follow-up sufficiently long and complete?

The patients included were randomized into either the percutaneous cholecystostomy group or the gallbladder aspiration group by means of the sealed envelope method after written informed consent had been obtained. (Subjects and methods 2nd paragraph lines 1-5 pg 194)

A prospective randomized controlled trial was done to compare and determine the effectiveness and safety of percutaneous cholecystostomy and gallbladder aspiration in cases of severe acute cholecystitis.(Discussion 4th paragraph lines 1-5 pg 195)

203 patients with acute cholecystitis were admitted. Of those 203 patients, 84 patients improved with antibiotic treatment.

Sixty-one patients were excluded on the basis of the exclusion criteria (refused consent,n= 48;pericholecystic liver abscess,n= 11;coagulopathy;n= 2).

Those patients underwent either percutaneous cholecystostomy or gallbladder aspiration except one patient who underwent emergency cholecystectomy because of spontaneous perforation of the gallbladder.

The results were analyzed per protocol; all patients who underwent percutaneous cholecystostomy after gallbladder aspiration as a salvage procedure were included in the analysis.(Statistical Analysis 2nd paragraph lines 1-4)

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VALIDITYGUIDES

Was the data analyzed on an intention-to-treat basis?

Was there adequate blinding of subjects and researchers?

Yes. No crossing over of treatment were done. The patients were all attributed to the group which they were randomized.

Of the 58 patients included, 30 were randomized to the percutaneous cholecystostomy group and 28 to the gallbladder aspiration group (Fig. 1).(Results 1st paragraph sentences 1-5 pg 194)

Blinding is not possible, since this is a surgical trial.Although, outcome events were assessed by investigators or adjunction committess who are not directly involved in the trial.Percutaneous cholecystostomy was performed by puncturing the gallbladder with an 18-gauge needle under sonographic guidance, followed by deployment of a 6.5- or 7-French pigtail catheter using the Seldinger technique.Gallbladder aspiration was carried out with a 21-gauge needle under sonographic guidance. The needle was removed immediatelyafter aspiration of gallbladder contents.Both procedures were performed by trained gastroenterologists.This study was approved by the institutionalreview board.(subjects and methods 2nd sentences 2-5)

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VALIDITYGUIDES

Were there similar baseline characteristics in each group?

Groups treated equally other than intervention?

Patient characteristics of the two groups were comparable except for ahigher proportion of patients with leukocytosis and its degree in the percutaneous cholecystostomy group( Results 2nd paragraph 4th sentence pg 194)

Those patients underwent either percutaneous cholecystostomy or gallbladder aspiration except one patient who underwent emergency cholecystectomy because of spontaneous perforation of the gallbladder. (Results 2nd paragraph 2nd sentence pg 194)

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CLINICALIMPORTANCE

How precise is the estimate of the treatment effect?

Confidence interval was not indicated. However, the reported p-value was p < 0.05, therefore, results are acceptable.

How large was the treatment effect?

Control = gallbladder aspiration (GA)Treatment = percutaneous cholecystotomy (PC)Death = failure to clinically respond within 72 hours

Measures Formulas Figures Interpretation

Risk in Control (Rc) Death Control / N Control 14 / 28 = 0.5

Risk in Treatment (Rt) Death Tx / N Tx 3 / 30 = 0.1

Absolute Risk Reduction (ARR) Rc – Rt 0.5 – 0.1 = 0.4 Failure is prevented in 40%

of pxs receiving PC

Relative Risk (RR) Rt / Rc 0.1 / 0.5 = 0.2 Risk of failure is now 20% compared to GA

Relative Risk Reduction (RRR) 1 – RR 1 – 0.2 = 0.8 80% reduction in failure

with PC compared with GA

Number Needed to Treat (NNT) 1 / ARR 1 / 0.4 = 2.5 Treat 3 patients to prevent

1 failure

p. 194, Results

p. 194, Results

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APPLICABILITY

Can the results be applied to my patient care?

Were all clinically important outcomes considered ?

The main clinical parameter used in the study was good clinical response within 72 hours of intervention (surrogate endpoint), which improved safety of elective surgery (cholecystectomy). Thus, yes, indirectly, clinically important outcomes were considered. p. 194, Results

Patient in the Case Population in the Study

Female Male and female

89 years old 27 – 89 years old, mean 62

(+) Hpn, DM, hemodynamic instability Pxs with no improvement after 24h of antibiotic tx

Severe abdominal pain Diagnostic criteria of acute cholecystitis: abdominal pain in 98% of pxs

Distended gallbadder, gallbladder wall thickening

Diagnostic criteria of acute cholecystitis: at least one of these sonographic findings – distended gallbladder, gallbladder wall thickening (>3mm), debris in the gallbladder

Yes, the results can be applied to our patient care. The patient meets most of the inclusion criteria and none of the exclusion criteria. However, presence of co-morbid conditions in the study population was not indicated. p. 193, subjects and methods

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APPLICABILITY

Is treatment feasible?

Yes, percutaneous cholecystotomy is available in the Philippines

Patient preferences

Current experience suggests that interventional radiological drainage can be performed without increasing the overall mortality rate. However, percutaneous cholecystotomy does not obviate the need for ultimate surgical removal of the gallbladder.

Percutaneous cholecystotomy is only a temporizing option in a seriously ill patient, and this should still be followed by cholecystectomy. But given that the patient is 89 years old with co-morbid conditions, the quality of life granted by this procedure until the need for cholecystectomy is warranted, might be enough.

Benefits vs. Harms