SALT LAKE CITY — Recruitment is underway for participants in the first U.S. study of laparoscopic adjustable banding for obese adolescents, Dr. Ai-Xuan Le Holterman said in a poster presentation at the annual meeting of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
Early data on the off-label use of the procedure for obese adolescents in the United States are the basis for the study protocol, which will recruit 50 patients and follow them for 5 years after the surgery. Ten adolescents have enrolled so far, and it may take 3 years before enrollment is complete because of the study's strict protocol, Dr. Holterman said.
The surgery seemed as effective in 10 adolescents as in 506 U.S. adults, said Dr. Holterman of the University of Illinois at Chicago. The adult data were drawn from patients who received laparoscopic adjustable gastric banding at the University of Illinois as part of the clinical trial that led to Food and Drug Administration approval in 2001 of the LAP-BAND device.
Dr. Holterman and her associates found that the surgery required 55 minutes in adolescents and 66 minutes in adults. Hospitalizations lasted 12 and 22 days, respectively. On average, body mass index (BMI) for adolescents fell from 49 kg/m
The adolescents had a much higher complication rate, however, with three patients (30%) developing pouch enlargement, compared with 11% of adults. The pouch enlargement required reoperation to reposition or replace the band in two adolescents (20%) and 2% of adults. More than 90% of pouch enlargements can be treated with band deflation, so the higher reoperation rate in adolescents probably reflects a delay in diagnosis of the complication.
Drawing on the results of their review, the investigators designed the trial's protocol to include closer and more frequent follow-up of the adolescents than is called for by adult protocols. So far, none of the adolescent patients enrolled in the trial have developed pouch enlargement.
In gastric bypass surgery, gastric stapling restricts food intake, and an intestinal bypass adds malabsorption to promote weight loss. In laparoscopic gastric banding, surgeons place an adjustable silicone band that induces weight loss by creating a small proximal gastric pouch. The outlet of the pouch is adjusted by controlling the lumen of the band through an inflatable reservoir accessed via a subcutaneous port.
“We encourage people to consider this before bypass because this is reversible and can be tailored to the changing lifestyle of the patient,” Dr. Holterman said. If the patient gets pregnant or ill and needs to eat more or needs more fluid, “we can adjust the band to accommodate for that.”
The impermanence of adjustable gastric bands is a drawback in the eyes of Dr. Michael Helmrath, a pediatric surgeon at Texas Children's Hospital, Houston. Experience in adults shows that the bands break in a few patients each year, necessitating replacement.
“You're dealing with a problem that is lifelong. There isn't an implantable device that's going to last the lifetime of a patient,” he said in an interview. Dr. Helmrath prefers to perform gastric bypass surgery for morbidly obese patients who fail other therapies.
Gastric bypass surgery, however, has taken a hit from two recent studies showing higher than expected rates of death and complications in some adults. In one large study, 40% of patients were readmitted to the hospital one or more times during the 3 years after gastric bypass, double their hospitalization rate in the 3 years before the surgery (JAMA 2005;294:1918–24). Another study found that 5% of Medicare patients receiving gastric bypass died within 30 days, more than double the death rates seen with other surgical procedures commonly performed on the elderly (JAMA 2005;294:1903–8).
We encourage people to consider banding before bypass because it is reversible and can be tailored to lifestyle changes. DR. HOLTERMAN
Plain anteroposterior radiograph shows the LAP-BAND device before adjustment.
Postoperative esophagogram with adjustment shows the LAP-BAND device in the proper position. Photos courtesy Dr. Ai-Xuan Le Holterman