Journal of vascular and interventional radiology : JVIR · 2016
Gastric Artery Embolization Trial for the Lessening of Appetite Nonsurgically (GET LEAN): Six-Month Preliminary Data.
Клиническое исследование I фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Syed Mubin I, Morar Kamal, Shaikh Azim, Craig Paul, Khan Omar, Patel Sumeet, Khabiri Hooman
Аннотация
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.
Предметные рубрики MeSH
AdultAngiography, Digital SubtractionAppetite RegulationArteriesBody Mass IndexEatingEmbolization, TherapeuticEndoscopy, GastrointestinalFemaleGastric EmptyingHealth StatusHumansMaleMiddle AgedObesity, MorbidPilot ProjectsProspective StudiesQuality of LifeStomachTime FactorsTreatment OutcomeWeight Loss