EUS - guided choledocho-duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction. A multi-center randomized controlled trial. (DRA-MBO trial)
Abstract
BACKGROUND AND AIMS
Several studies have compared primary EUS-guided biliary drainage to ERCP with insertion of metal stents in unresectable malignant distal biliary obstruction (MDBO) and the results were conflicting. The aim of the current study was to compare the outcomes of the procedures in a large-scale study.
METHODS
This was a multi-center international randomized controlled study. Consecutive patients admitted for obstructive jaundice due to unresectable MBDO were recruited. Patients were randomly allocated to receive ECDS or ERCP for drainage. The primary outcome was the 1-year stent patency rate. Other outcomes included technical success, clinical success, adverse events, time to stent dysfunction, re-intervention rates and overall survival.
RESULTS
Between January 2017 to February 2021, 155 patients were recruited (ECDS 79, ERCP 76). There were no significant differences in 1-year stent patency rates (ECDS 91.1% vs ERCP 88.1%, P = 0.52). The ECDS group had significantly higher technical success (ECDS 96.2% vs ERCP 76.3%, P < 0.001) whilst clinical success was similar (ECDS 93.7% vs ERCP 90.8%, P = 0.559). The median (IQR) procedural time was significantly shorter in the ECDS group [ECDS 10 (5.75 - 18) vs ERCP 25 (14 - 40) minutes, P < 0.001]. The rate of 30-day adverse events (P = 1) and 30-day mortality (P = 0.53) were similar.
CONCLUSION
Both procedures could be options for primary biliary drainage in unresectable MDBO. ECDS was associated with higher technical…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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