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 Surgery 1 and Pediatric Surgery 2, and the New Hope Pediatric & Adolescent Weight Management Project at the University of Illinois at Chicago

The laparoscopic adjustable gastric banding 2 Proximal Gastric Pouch LAGB Gastric bypass % EWL at 5 year 56%58% Mortality 1/20001/200 Complications 11%25-40% Chapman et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery 2004;135: 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 Bioenterics 3 Port Lap Band 10 cm Lap Band VG Balloon

LapBand® at 45 o Proximal Gastric pouch Normal barium swallowNormal radiograph Band at 45 o 7

Patient characteristicsAdolescent n = 10 Adult n = 506 p value Age (years)18 (16-20) 41 (21-65) Preoperative BMI (kg/m²)49±8 47  Operative time (min)55±22 66  Length of stay (hs)12±6 22  Follow up BMI postop% EWLBMI postop% EWL  3 months 42±927±19 42  718   6 months 36±1151±32 39  831   12 months 37±1050±26 37  840   18 months 34±757±23 37  639  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

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“Conflicted” Adolescents Want to lose weight and look like their peers Want to eat like their peers

Pouch enlargement Band at 45 o Band at 0 o Band < 45 o 8

Adult protocolModified Adolescent protocol LAPBAND size: 10 or 11 cm Diet Week 1: Liquid Week 2-3: Blended diet Week 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 sensation Follow up: RTC suggested 6 times/year or if meet readjustment criteria LAPBAND size: 11 cm VG Diet Same 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 contact 10

COMPREHENSIVE AND INTEGRATED CARE The surgeons, the pediatricians, the support team, the research team The Adult Bariatric Surgery team- SUPPORT for the Adolescent Bariatric team: Advanced laparoscopic surgeon Former PI in the FDA trial B; >700 cases of LAGB EXPERIENCE 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 patients Department of Surgery, Division of Pediatric Surgery Advanced laparoscopic surgeon ASBS criteria THE TEAM CONCEPT 1

Team Clinical Evaluation Psychologist Adolescent Pediatrician Nutritionist Physical Therapist PNP (Nurse Coordinator) Pediatric Surgeon

FDA trial 8 patients Ages yr Ave. SD 16 +/-.91 BMI Ave. SD / RESULTS Weight loss30-48 lbs 35+/ lbs 83+/-20 % EWL14-38% 28+/-10% 36-58% 44+/-12% Complications0% 0% Readmission1/8 ER visit for Barium swallow (negative) 3 months6 months Range Ave+/-SD RangeAve+/-SD Comorbidities 50 % Sleep apnea 50 % hypertension 25 % hyperlipidemia 44 % Insulin resistance 70 % Fatty liver disease 37.5 % Dysmenorrhea 25 % 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 SUMMARY 11 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 = – = –0.056%<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 Nutritionist Exercise specialist (Physical therapist) The Adolescent Bariatric Program Support Team: Hospital Administrator Project Coordinator Medical insurance Coordinator Public relation Coordinator The Researchers School of Medicine (obesity-related liver disease, metabolic syndrome Inflammatory states, pulmonary disease) School of Nutrition (Body fat composition and fat metabolism School 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 indices Coags Hematology Testing: Barium Swallow Esophageal manometry Anesthesia evaluation DXA Liver & GB U/S Bone Age Sleep study if indicated by pulmonologist FOLLOW UP Labs followed q 3 months for 1 st year Then q year & prn. Manometry, Ba Swallow, Liver U/S repeated yearly & prn