Gut · 2025
Endoscopic or surgical gastroenterostomy for malignant gastric outlet obstruction: a randomised trial.
Equivalence TrialСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Bang Ji Young, Puri Rajesh, Lakhtakia Sundeep, Thakkar Shyam, Waxman Irving, Siddiqui Imran, Arnold Kristen, Chaudhary Adarsh, Mehta Shubham, Singh Amanjeet, Venkat Rao Guduru, Basha Jahangeer, Gupta Rajesh, Modak Shreeyash, Singh Shailendra, Boone Brian, Dautel Philip, Dixon Matthew E B, Kim Hyungjin Myra, Sutton Bryce, Arnoletti Juan Pablo, Rösch Thomas, Varadarajulu Shyam
Аннотация
BACKGROUND: Although surgical gastrojejunostomy (SGJ) is the standard method for palliation of gastric outlet obstruction (GOO), an endoscopic method-endoscopic ultrasound-guided gastroenterostomy (EUS-GE)-has been proposed as a novel, less invasive approach.
OBJECTIVE: We compared both methods to determine whether clinical outcomes for EUS-GE are superior to surgery.
DESIGN: We conducted a multicentre, randomised superiority trial of patients with malignant GOO to receive either EUS-GE or SGJ. Primary endpoint was composite measure, consisting of Gastric Outlet Obstruction Scoring System (GOOSS) score of 0 or 1 at hospital discharge, need for reinterventions or supplemental nutrition, or procedure-related adverse events during 6-month follow-up or until death. Secondary endpoints were time to solid diet, length of hospitalisation, health-related quality of life (HRQoL) and treatment costs.
RESULTS: 74 patients were randomly assigned to EUS-GE (38 patients) or SGJ (36 patients). Primary endpoint occurred in 7.9% of patients who received EUS-GE and 38.9% in SGJ (risk difference -31.0%, 95% CI -47.6% to -11.4%, p=0.002). EUS-GE was associated with more rapid advancement to solid diet (median 2 days (P25-P75, 2-3) vs 5 days (P25-P75, 3.5-9)), shorter hospitalisation (median 3 days (P25-P75, 3-6) vs 9 days (P25-P75, 6-12.5)), better HRQoL for physical (p=0.0016) and social functioning (p=0.011) and lower treatment costs (US$33 934 vs US$51 437, difference -US$17 503 (95% CI -US$27 807 to -US$7920)).
CONCLUSION: In this randomised trial, EUS-GE was superior to SGJ with regards to oral intake, need for reinterventions or supplemental nutrition, length of hospitalisation, quality of life and treatment costs.
TRIAL REGISTRATION NUMBER: NCT05548114.
OBJECTIVE: We compared both methods to determine whether clinical outcomes for EUS-GE are superior to surgery.
DESIGN: We conducted a multicentre, randomised superiority trial of patients with malignant GOO to receive either EUS-GE or SGJ. Primary endpoint was composite measure, consisting of Gastric Outlet Obstruction Scoring System (GOOSS) score of 0 or 1 at hospital discharge, need for reinterventions or supplemental nutrition, or procedure-related adverse events during 6-month follow-up or until death. Secondary endpoints were time to solid diet, length of hospitalisation, health-related quality of life (HRQoL) and treatment costs.
RESULTS: 74 patients were randomly assigned to EUS-GE (38 patients) or SGJ (36 patients). Primary endpoint occurred in 7.9% of patients who received EUS-GE and 38.9% in SGJ (risk difference -31.0%, 95% CI -47.6% to -11.4%, p=0.002). EUS-GE was associated with more rapid advancement to solid diet (median 2 days (P25-P75, 2-3) vs 5 days (P25-P75, 3.5-9)), shorter hospitalisation (median 3 days (P25-P75, 3-6) vs 9 days (P25-P75, 6-12.5)), better HRQoL for physical (p=0.0016) and social functioning (p=0.011) and lower treatment costs (US$33 934 vs US$51 437, difference -US$17 503 (95% CI -US$27 807 to -US$7920)).
CONCLUSION: In this randomised trial, EUS-GE was superior to SGJ with regards to oral intake, need for reinterventions or supplemental nutrition, length of hospitalisation, quality of life and treatment costs.
TRIAL REGISTRATION NUMBER: NCT05548114.