SAN FRANCISCO — Teens who underwent laparoscopic gastric banding surgery had improvements in hemoglobin A1c, 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 providers 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.
At Columbia University, 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.
Values for the children were assigned based on references; what might be considered normal for an adult is not so for a pediatric patient, according to Dr. Fennoy. Overall, the 14 patients have lost an average of 20 pounds each. The body mass index z score declined from 2.88 to 2.69, and waist circumference declined from 145.5 cm to 132.2 cm. Hemoglobin A1c values declined from 5.59% to 5.48%, while 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, 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, which really is not present from pharmacologic and lifestyle interventions,” she noted. 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.