Surgical endoscopy · 2026
Magnetic vs stapled technique in jejuno-ileal bipartition: one-year outcomes.
СтатьяСравнительное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Fried Martin, Michalsky D, Buchwald J N, Charpentier D, Schneider J, Gagner Michel
Аннотация
BACKGROUND: Minimally invasive side-to-side magnetic jejuno-ileal (JI) bipartition (MagJI) is a novel treatment for patients with mild obesity and/or type 2 diabetes (T2D) that obviates complications from enterotomies and retained foreign materials and may provide efficacy equivalent to the standard stapled JI procedure.
METHODS: The comparative, non-randomized, non-inferiority study evaluated the efficacy of magnetic vs stapled JI in adults with body mass index (BMI, kg/m2) ≥ 30.0- ≤ 39.9 and T2D matched by age and sex. After introduction of two linear magnets by swallowing and/or endoscopy beyond the ligament of Treitz, magnets were guided laparoscopically to target ileal and jejunal locations and apposed across bowel walls, initiating compression anastomosis.
ENDPOINTS: weight, BMI, HbA1C, and fasting plasma glucose (FPG) reduction.
RESULTS: Between March1, 2023, and June30, 2024, patients were enrolled and matched for comparison. No trocar site infection or severe adverse event related to the device or procedure in either group. At 1 year, regression-adjusted outcomes for an average baseline patient were as follows: weight 91.3 kg (stapled) vs 93.3 kg (magnetic); BMI 31.0 vs 31.3; HbA1C 56.2 vs 41.5 mmol/mol; FPG 8.6 vs 5.4 mmol/L. Non-inferiority was demonstrated for BMI (p = 0.017), HbA1C (p < 0.001), and FPG (p < 0.001), but not weight (p = 0.091).
CONCLUSIONS: Early quantitative evidence demonstrated that magnetic JI achieved metabolic outcomes (BMI, HbA1C, and FPG) non-inferior to those of stapled JI at 1 year. Minimally invasive MagJI is a safe, effective, anatomy sparing technique that may offer a patient-accessible metabolic/bariatric surgical option to treat mild obesity and T2D.
CLINICALTRIALS: gov Identifier: NCT#06232746.
METHODS: The comparative, non-randomized, non-inferiority study evaluated the efficacy of magnetic vs stapled JI in adults with body mass index (BMI, kg/m2) ≥ 30.0- ≤ 39.9 and T2D matched by age and sex. After introduction of two linear magnets by swallowing and/or endoscopy beyond the ligament of Treitz, magnets were guided laparoscopically to target ileal and jejunal locations and apposed across bowel walls, initiating compression anastomosis.
ENDPOINTS: weight, BMI, HbA1C, and fasting plasma glucose (FPG) reduction.
RESULTS: Between March1, 2023, and June30, 2024, patients were enrolled and matched for comparison. No trocar site infection or severe adverse event related to the device or procedure in either group. At 1 year, regression-adjusted outcomes for an average baseline patient were as follows: weight 91.3 kg (stapled) vs 93.3 kg (magnetic); BMI 31.0 vs 31.3; HbA1C 56.2 vs 41.5 mmol/mol; FPG 8.6 vs 5.4 mmol/L. Non-inferiority was demonstrated for BMI (p = 0.017), HbA1C (p < 0.001), and FPG (p < 0.001), but not weight (p = 0.091).
CONCLUSIONS: Early quantitative evidence demonstrated that magnetic JI achieved metabolic outcomes (BMI, HbA1C, and FPG) non-inferior to those of stapled JI at 1 year. Minimally invasive MagJI is a safe, effective, anatomy sparing technique that may offer a patient-accessible metabolic/bariatric surgical option to treat mild obesity and T2D.
CLINICALTRIALS: gov Identifier: NCT#06232746.