Teens do well 6 months after gastric banding.

SAN FRANCISCO -- Teenagers who underwent laparoscopic gastric banding surgery had improvements in hemoglobin [A.sub.1c], triglyceride, and C-reactive protein measures, according to 6-month follow-up results for 14 patients.

The Lap-Band, made by Inamed Inc., a division of Allergan Inc., was approved by the Food and Drug Administration in 2001 for adults. It has been used off label for adolescents, but many institutions are discouraging those unapproved procedures and are urging clinicians instead to enroll patients at one of the three study sites, said Dr. Ilene Fennoy; who presented results from the Columbia University (New York) site at the annual meeting of the Endocrine Society.

During the procedure, the Lap-Band is placed around the most proximal portion of the stomach, leaving a 30- to 50-mL pouch. The band can be adjusted to further restrict the stomach.

At Columbia, 38 adolescents aged 14-17 years have received the Lap-Band, and 14 of those have had 6 months of follow-up, said Dr. Fennoy, a pediatrician at Columbia and medical director of the comprehensive adolescent bariatric surgery program at the Morgan Stanley Children's Hospital of New York-Presbyterian. Study participants, all of whom were Tanner stage IV or V, underwent psychological evaluation and had to have demonstrated failure to lose weight after participation in a documented weight-loss program for at least 6 months, Dr. Fennoy said in an interview.

Values for the children were assigned based on references; what might be considered normal for an adult is not so for a pediatric patient, said Dr. Fennoy. Overall, the 14 patients lost an average of 20 pounds each. The body mass index z score declined from 2.88 to 2.69, waist circumference from 145.5 cm to 132.2 cm. [HbA.sub.1c] values declined from 5.59% to 5.48%; triglycerides went from 128.9 mg/dL to 95 mg/dL. C-reactive protein levels dropped from 9.4 mg/L to 5.7 mg/L. There were no significant differences in blood pressure.

Dr. Fennoy said that the adolescents tolerated the surgery "very well," and returned to school within a week of surgery, but that "the hardest part for them usually is eating smaller portions." Postoperative complications included some increased bleeding in one patient and the need to reposition a band in another. The study cohort will be followed for 5 years, Dr. Fennoy said.

Overall, "for the extremely obese adolescent, [the Lap-Band] offers the opportunity to lose significant weight," she noted, adding that maintaining weight loss is "'still all about lifestyle change."

Her data will be part of Allergan's application to the FDA for approval of the Lap-Band in adolescents, but the company is not funding the study, Dr. Fennoy said. She had no disclosures to report.

BY ALICIA AULT

Associate Editor, Practice Trends