Background:EUS-guided balloon-occluded gastrojejunostomy bypass (EPASS) is an emerging technique for management of malignant gastric outlet obstruction. However, how the modality compares to conventional duodenal stenting is uncertain.

Aims and hypothesis:The aim of the current study is to compare the efficacy of EPASS versus uncovered pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We hypothesize that EPASS could reduce the re-intervention rates when compared to DS

Methods

This would be a prospective multi-centered randomized controlled study, comparing the use of EPASS versus DS in patients suffering unresectable malignant gastric outlet obstruction. Consecutive patients with confirmed unresectable gastro-duodenal or pancreatico-biliary malignancies causing gastric outlet obstruction would be included. The primary outcome measurement is the 6-month re-intervention rate. Secondary outcomes include technical and clinical success, adverse events rate, mortality, pre- and post stenting gastric outlet obstruction scores (GOOS), causes of stent dysfunction, the duration of stent patency, cost and quality of life assessment scores.

Analysis

All outcomes would be analyzed according to the intention-to-treat principle. Comparisons would be made by Chi-square test or Fisher exact test for categorical data, Mann-Whitney U for non-parametric continuous data. Cumulative stent patency and patient survival times are analyzed using the Kaplan–Meier method and compared using the log-rank test.