EUS-guided GastroEnterostomy for management of malignant Gastric Outlet Obstruction: a prospective cohort study with matched comparison with Enteral Stenting

Background and aims: Retrospective studies on malignant Gastric Outlet Obstruction (mGOO) highlighted several advantages of EUS-guided Gastroenterostomy (EUS-GE) over enteral stenting (ES). However, no prospective evidence is available. The aim of this study was to report on clinical outcomes of EUS-GE in a prospective cohort study, with a subgroup comparison to ES. Methods: All consecutive patients endoscopically treated for mGOO between Dec-2020 and Dec-2022 in a tertiary, academic center were enrolled in a Prospective Registry (PROTECT, NCT04813055) and followed every 30 days to register efficacy/safety outcomes. EUS-GE and ES cohorts were matched according to baseline frailty and oncological disease. Results: 104 patients were treated for mGOO during study interval, of which 70 [male 58.6%; median age=64 [IQR 58-73]; 75.7% pancreatic cancer, 60.0% metastatic] underwent EUS-GE through the Wireless Simplified Technique (WEST). Technical success was 97.1%, whereas clinical success was 97.1% after a median of 1.5 [IQR 1-2] days. Adverse events occurred in 9 (12.9%) patients. After median follow-up of 105 [49-187] days, symptoms recurrence was 7.6%.In the matched comparison versus ES (28 patients per arm), EUS-GE patients experienced higher and faster clinical success (100% vs. 75.0%, p=0.006), reduced recurrences (3.7% vs. 33.3%, p=0.007) and a trend towards shorter time-to-chemotherapy. Conclusions: In this first, prospective, single-center comparison, EUS-GE showed excellent efficacy in relieving mGOO, with an acceptable safety profile and long-term patency, and several clinically significant advantages over ES. Whilst awaiting randomized trials, these results might endorse EUS-GE as first line strategy for mGOO, where adequate expertise is available.