Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band
system in the morbidly obese adolescent population in the United States. We also propose to
take advantage of the opportunity for liver biopsy and the data collected for the FDA study
in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic
fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the
course of the NAFLD disease in adolescents who have undergone weight loss, including the
progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What
are the factors implicated in this progression and 4) Is there a link between the excess
visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and
NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a
significantly less morbid and reversible surgical option for weight loss.

Inclusion Criteria:

- Ages 14 through 17

- BMI greater than 40

- BMI 35 to 40 and also having an obesity related comorbidity

- Have a history of working in a multidisciplinary weight loss program utilizing
nutritional training, behavior modification, and activity training

Exclusion Criteria:

- Subject history of congenital or acquired anomalies fo the gastrointestinal tract

- Severe cardiopulmonary or other serious organic disease

- Severe coagulopathy

- Hepatic insufficiency or cirrhosis

- History of bariatric gastric or esophageal surgery

- History of intestinal obstruction or adhesive peritonitis

- History of esophageal motility disorders

- Type I diabetes