EUS-GUIDED BALLOON OCCLUDED GASTROJEJUNOSTOMY BYPASS (EPASS) VERSUS DUODENAL STENT FOR UNRESECTABLE MALIGNANT GASTRIC OUTLET OBSTRUCTION (DRA-GOO)

Background
EUS-guided gastroenterostomy (EUS-GE) is a novel method for palliating gastric outlet obstructon due to unresectable malignancies. The procedure is associated with high technical and success rates and potentially lower recurrent obstructions, reinterventions and better gastric outlet obstruction scores. However, results from randomized controlled studies are lacking. Hence, the aim of the current study is thus to compare EUS-GE with the use of a double balloon occluder (EPASS) and duodenal stent (DS) under a randomized setting. We hypothesize that EPASS could reduce the re-intervention rates when compared to DS.
Methods
The was a prospective multi-centered randomized controlled study conducted between December 2020 to February 2022 in 7 institutions. We included consecutive patients suffering from malignant gastric outlet obstruction due to unresectable primary gastro-duodenal or pancreatico-biliary malignancies. Included patients were randomized to receive EPASS or DS. The primary outcome measurement was 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.
Results
During the study period, 97 patients were included (EPASS 48, DS 49). There were no significant differences in background demographics. The EPASS group was associated with significantly better 6 month stent patency rate (97.9% vs 71.4%, P < 0.001) and mean stent patency days [176.7 (22.7) vs 152.9 (59.1), P = 0.013]. The reintervention rate was significantly lower in the EPASS group (2.1% vs 28.6%, P < 0.001). The 1 month gastric outlet obstruction score was significantly better in the EPASS group [2.3 (0.7) vs 1.9 (0.95), P = 0.031]. There were no significant differences in technical and clinical success rates (95.8% vs 100%, P = 0.242 and 100% vs 91.7%, P = 0.117 respectively), procedural time [40.3 (16.6) vs 37.8 (91.7), P = 0.865], hospital stay [7.1 (9.4) vs 9.0 (7.2), P = 0.289], 30-day mortality [5 (10.4) vs 1 (2), P = 0.097] and 30-day adverse events [7 (14.6) vs 7 (14.6), P = 1].
Conclusions
EPASS significantly improved the stent patency and eating functions in patients suffering from malignant gastric outlet obstruction. This should be the procedure of choice when the expertise is available.