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Clinical Trial, Phase I
Journal Article
Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data.
PURPOSE: To report 6-month safety and efficacy results of a pilot study of left gastric artery (LGA) embolization for the treatment of morbid obesity (ie, body mass index [BMI] > 40 kg/m(2)).
MATERIALS AND METHODS: Four white patients (three women; average age, 41 y [range, 30-54 y]; mean weight, 259.3 lbs [range, 199-296 lbs]; mean BMI, 42.4 kg/m(2) [range, 40.2-44.9 kg/m(2)]) underwent an LGA embolization procedure with 300-500-µm Bead Block particles via right common femoral or left radial artery approach. Follow-up included upper endoscopy at 3 days and 30 days if necessary and a gastric emptying study at 3 months. Tracked parameters included adverse events; weight change; ghrelin, leptin, and cholecystokinin levels; and quality of life (QOL; by Short Form 36 version 2 questionnaire).
RESULTS: Three minor complications (superficial gastric ulcerations healed by 30 d) occurred that did not require hospitalization. There were no serious adverse events. Average body weight change at 6 months was -20.3 lbs (n = 4; range, -6 to -38 lbs), or -8.5% (range, -2.2% to -19.1%). Average excess body weight loss at 6 months was -17.2% (range, -4.2% to -38.5%). Patient 4, who had diabetes, showed an improvement in hemoglobin A1c level (7.4% to 6.3%) at 6 months. QOL measures showed a general trend toward improvement, with the average physical component score improving by 9.5 points (range, 3.2-17.2) and mental component score improving by 9.6 points (range, 0.2-19.3) at 6 months.
CONCLUSIONS: Preliminary data support LGA embolization as a potentially safe procedure that warrants further investigation for weight loss in morbidly obese patients.
MATERIALS AND METHODS: Four white patients (three women; average age, 41 y [range, 30-54 y]; mean weight, 259.3 lbs [range, 199-296 lbs]; mean BMI, 42.4 kg/m(2) [range, 40.2-44.9 kg/m(2)]) underwent an LGA embolization procedure with 300-500-µm Bead Block particles via right common femoral or left radial artery approach. Follow-up included upper endoscopy at 3 days and 30 days if necessary and a gastric emptying study at 3 months. Tracked parameters included adverse events; weight change; ghrelin, leptin, and cholecystokinin levels; and quality of life (QOL; by Short Form 36 version 2 questionnaire).
RESULTS: Three minor complications (superficial gastric ulcerations healed by 30 d) occurred that did not require hospitalization. There were no serious adverse events. Average body weight change at 6 months was -20.3 lbs (n = 4; range, -6 to -38 lbs), or -8.5% (range, -2.2% to -19.1%). Average excess body weight loss at 6 months was -17.2% (range, -4.2% to -38.5%). Patient 4, who had diabetes, showed an improvement in hemoglobin A1c level (7.4% to 6.3%) at 6 months. QOL measures showed a general trend toward improvement, with the average physical component score improving by 9.5 points (range, 3.2-17.2) and mental component score improving by 9.6 points (range, 0.2-19.3) at 6 months.
CONCLUSIONS: Preliminary data support LGA embolization as a potentially safe procedure that warrants further investigation for weight loss in morbidly obese patients.
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