Endoscopic Ultrasound-Guided Gastroenterostomy Versus Enteral Stenting for Palliation of Malignant Gastric Outlet Obstruction: An International Randomized Trial

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Aims Endoscopic enteral stenting (ES) and endoscopic ultrasound-guided gastroenterostomy (EUS-GE) are established minimally invasive palliative therapies for malignant gastric outlet obstruction (mGOO). To date, only one randomized controlled trial has compared these techniques, and it required a double-balloon-assisted EUS-GE approach that is not routinely available. In this multicenter randomized trial, we compared EUS-GE and ES using operator-selected techniques to assess efficacy, safety, and reintervention in patients with mGOO. Methods In this international multicenter 1:1 randomized trial, adults with unresectable, symptomatic mGOO (GOO symptom score≤1) were randomized to EUS-GE or ES and followed for 1 year. The primary endpoint was 3-month GOO recurrence, defined as recurrent symptoms with endoscopic or radiographic confirmation of stent dysfunction. Secondary endpoints included procedure-related adverse events (AEs, based on ASGE lexicon) with serious AEs defined as moderate or severe, technical success, clinical success (≥1-point improvement in GOO score within 7 days), GOO recurrence at 6 and 12 months, reintervention for stent dysfunction at 3, 6, and 12 months, and overall survival. Analyses were conducted on an intention-to-treat basis. Results Between Oct 2020 and March 2025, 112 patients from five institutions were randomized (EUS-GE, n=57; ES, n=55). The median age was 63 years in both groups. Baseline characteristics were well balanced between groups. Technical success was achieved in 98.2% of EUS-GE and 94.5% of ES cases (p=0.700). Clinical success occurred in 87.7% vs 76.4% (p=0.330). GOO recurrence was significantly lower with EUS-GE compared with ES based on cumulative incidence analysis accounting for death as a competing risk (Gray’s test p=0.004). Recurrence rates were 0% in the EUS-GE group vs 3.8% in the ES group at 3 months, 0% vs 7.7% at 6 months, and 0% vs 15.4% at 12 months. Similarly, cumulative incidence of reintervention was significantly lower with EUS-GE (Gray’s test p=0.003). Reintervention rates were 0% vs 5.8% at 3 months, 0% vs 9.6% at 6 months, and 0% vs 15.4% at 12 months. Procedure-related AEs occurred in 8.8% of EUS-GE and 7.3% of ES patients (p=1.00). Serious procedure-related AEs occurred in 0% vs 5.5%, respectively (p=0.115). In the ES group, serious events included stent migration, perforation, and aspiration requiring ICU admission. Median overall survival was 4.4 months in the EUS-GE group and 3.6 months in the ES group (log-rank p=0.774). Conclusions In this international randomized trial, EUS-GE achieved similar technical and clinical success to ES in patients with mGOO, with significantly lower GOO recurrence and reintervention rates and a comparable safety profile. Publication History Article published online: 05 June 2026 © 2026. European Society of Gastrointestinal Endoscopy. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

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