Laparoscopic Adjustable Gastric Banding for the treatment of adolescent morbid obesity.The University of Illinois at Chicago experience

Holterman M 2, Browne A 2, Horgan S 1 Browne N 2 and Holterman A 2. From the Department of Surgery, Divisions of Minimally Invasive Surgery1 and Pediatric Surgery 2, and the New Hope Pediatric & Adolescent Weight Management Project at the University of Illinois at Chicago

The laparoscopic adjustable gastric banding2

ProximalGastricPouch

LAGB Gastric bypass

% EWL at 5 year 56% 58%Mortality 1/2000 1/200Complications 11% 25-40%

Chapman et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery 2004;135:326-351

World literature review-Adult

• 1999 The University of Illinois at Chicago (UIC) - FDA trial B

• 2001 FDA approval for the LAP-BAND® device for laparoscopic adjustable gastric banding (LAGB) weight loss procedure in adults

• 2004 (December) UIC receives FDA IDE for Lap-Band placement in 50 morbidly obese adolescents: A safety and efficacy trial

The FDA trial for “LAGB® Laproscopic adjustable gastric banding as a treatment for morbid obesity in adolescents” at UIC

4

LapBand® by Bioenterics3

Port

Lap Band 10 cm Lap Band VG

Balloon

LapBand®at 45o

ProximalGastric pouch

Normal barium swallowNormal radiograph

Bandat 45o

7

 Patient characteristics Adolescentn = 10

  Adultn = 506

  p value

Age (years) 18 (16-20)   41 (21-65)    

Preoperative BMI (kg/m²) 49±8   478   0.6

Operative time (min) 55±22   6626   0.8

Length of stay (hs) 12±6   2225   0.8

Follow up BMI postop % EWL BMI postop % EWL %EWL

  3 months 42±9 27±19 427 1811 0.7

  6 months 36±11 51±32 398 3116 0.5

  12 months 37±10 50±26 378 4023 0.8

  18 months 34±7 57±23 376 3919 0.6

Complications

●Pouch enlargement (PE) 3 (30%)

 

58 (11%)

 

0.1

 Reoperations for PE 2 (20%)* at 10 and 16 months

post LAGB

9 (2%)* 0.004*

Pre FDA RESULTS on “off label” patients 5

Excess weight loss (EWL)

0

15

30

45

60

75

90

3 6 12 18

Months follow up

% E

WL

Adolescent

Adult

6

“Conflicted” Adolescents

• Want to lose weight and look like their peers

• Want to eat like their peers

Pouch enlargement

Band at 45o

Band at 0o Band < 45o

8

Adult protocol Modified Adolescent protocolLAPBAND size: 10 or 11 cm

DietWeek 1: LiquidWeek 2-3: Blended dietWeek 4-6: Soft Food.Week 7 and after: 3 small (<4oz) meals/day

No liquid with meals Eat slowly and chew well Stop eating when full

Adjustment (using barium swallow)First adjustment at 6 weeks Readjustment criteria 1) if no longer feels full with meals 2) if do not loose >5lbs/month or > 2lb/wk 3) increased hunger sensationFollow up: RTC suggested 6 times/year or if meet readjustment criteria

LAPBAND size: 11 cm VG

DietSame

Adjustment same Readjustment criteria Same

Follow up: 1. RTC 1wk., 6 wks, then monthly. 2. FDA study visits: q 3 m x 1 yr,

& q 6m x 4yr 3. Close phone and Email contact

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COMPREHENSIVE AND INTEGRATED CAREThe surgeons, the pediatricians, the support team, the research team •The Adult Bariatric Surgery team-

SUPPORT for the Adolescent Bariatric team:Advanced laparoscopic surgeonFormer PI in the FDA trial B; >700 cases of LAGBEXPERIENCE in LAGB surgical and medical management CONTINUITY OF CARE for the adolescent bariatric patients

•The Adolescent Bariatric Surgery team. The PRIMARY care surgeons for the patientsDepartment of Surgery, Division of Pediatric SurgeryAdvanced laparoscopic surgeonASBS criteria

THE TEAM CONCEPT 1

Team Clinical Evaluation

• Psychologist

• Adolescent Pediatrician

• Nutritionist

• Physical Therapist

• PNP (Nurse Coordinator)

• Pediatric Surgeon

FDA trial

8 patientsAges 15-17 yr

Ave. SD 16 +/- .91BMI 36-75

Ave. SD 49.5 +/- 13.1

RESULTS

Weight loss 30-48 lbs 35+/-8 56-120 lbs 83+/-20% EWL 14-38% 28+/-10% 36-58% 44+/-12%Complications 0% 0%Readmission 1/8 ER visit

for Barium swallow (negative)

3 months 6 months Range Ave+/-SD Range Ave+/-SD

Comorbidities 50 % Sleep apnea50 % hypertension25 % hyperlipidemia44 % Insulin resistance70 % Fatty liver disease37.5 % Dysmenorrhea25 % Depression

Length of surgery (Ave. 56 minutes) Length of stay (per protocol) (23 hrs)

In this small early series of the FDA trial, LAGB as a treatment for MO in the adolescents:

1) Is associated with short operative time, brief hospital stay and no mortality. 2) Is effective and safe

SUMMARY11

The highest challenge of LAGB treatment for morbid obesity in the adolescents is the post-operative management. Close and long term follow-up, ensuring diet compliance and maintaining a high index of suspicion for early detection and treatment of pouch dilatation are essential.

CONCLUSION

If this was your child, what would you do?

• 1/200 vs 1/2000– Operate on 100,000 children: 500 vs 50

• 3 to 4 fold greater morbidity• Probably equal long term efficacy• Compliance problems either way• ??LAGB first and if not successful:->>> gastric

bypass– 0.20 X 0.03 = 0.006– 0.006 + 0.05 = 0.056– 0.056%<0.5% (9-fold safer)

• I would insist on a BAND

The Adolescent Bariatric Medical Team:Adolescent obesity specialist (adolescent pediatrician)Pediatric subspecialties (pulmonology, hepatology, etc)

The Adolescent Bariatric Clinical Support Team:Nurse Coordinator (Pediatric Nurse Practitioner)Psychologist NutritionistExercise specialist (Physical therapist)

The Adolescent Bariatric Program Support Team:Hospital AdministratorProject CoordinatorMedical insurance CoordinatorPublic relation Coordinator

The ResearchersSchool of Medicine (obesity-related liver disease, metabolic syndrome

Inflammatory states, pulmonary disease)School of Nutrition (Body fat composition and fat metabolismSchool of Public Health ( Economics of obesity, Diet/nutrition and

environmental factors)

• Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement.

• History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulapathy; hepatic insufficiency or cirrhosis.

• Pregnancy or intention of becoming pregnant in the next 12 months.• Presence of psychiatric problems or immaturity which would compromise

cooperation with the study protocol.• History of previous bariatric surgery, intestinal obstruction or adhesive

peritonitis.• Presence of localized or systemic infection at the time of surgery.• Chronic use of aspirin and/or non-steroidal anti-inflammatory medications

and unwillingness to discontinue the use of these concomitant medications.• History of gastric or esophageal surgery.• Use of weight loss medications.• History of esophageal dysmotility disorders.• Eating disorders.

EXCLUSION CRITERIA FDA Study

INCLUSION CRITERIA FDA Study

The 1991 NIH Consensus Development Conference on Gastrointestinal Surgery for Severe Obesity guidelines for bariatric surgery :

•Severely obese patients with a BMI (body-mass index) > 40 Kg/m2 or patients with a BMI > 35 Kg/m2 with coexisting morbidities.•Adolescents >14 y/o to < 18 y/o•Tanner Stage IV• > 5 years hx of obesity• > 6 months of supervised weight loss

LAGB® Laparoscopic Adjustable Gastric Banding As A Treatment for Morbid Obesity in Adolescents

FDA Protocol

1

PREOP SURGICAL EVALUATION

Labs:Metabolic syndrome Insulin resistance Non alcoholic fatty liver disease Baseline nutritional indicesCoagsHematology

Testing:Barium SwallowEsophageal manometryAnesthesia evaluationDXALiver & GB U/SBone AgeSleep study if indicated by pulmonologist

FOLLOW UP

Labs followed q 3 months for 1st year Then q year & prn.

Manometry, Ba Swallow, Liver U/S repeated yearly & prn