Eus-Guided Choledocho-Duodenostomy Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction. a Multi-Centered Randomized Controlled Trial (DRA-MBO TRIAL)

Aims EUS – guided choledocho-duodenostomy (ECDS) is an established option for bile duct drainage in unresectable malignant distal common bile duct (CBD) strictures when endoscopic retrograde cholangiopancreatography (ERCP) fails. The aim of the current study is to compare primary ECDS versus ERCP with CSEMS in unresectable malignant distal CBD strictures.

Methods This was an international multi-centered randomized controlled study conducted amongst 12 high-volume institutions. Consecutive patients admitted for obstructive jaundice due to unresectable primary malignant distal CBD strictures were recruited. The patients were randomized to receive either ECDS with a cautery enhanced lumen apposing stent (Hot AXIOS, Boston Scientific, Marlborough, USA) or ERCP with CSEMS (Figure 1). The primary outcome was the 1-year stent patency rate. Secondary outcomes included technical success, clinical success, adverse events, re-intervention rates and mortality.

Results Between January 2017 to November 2020, 158 patients were recruited in to the study (79 ECDS and 79 ERCP). There were no differences in background demographics (Table 1). The majority of patients suffered from unresectable locally advanced pancreatic adenocarcninoma. ECDS was associated with significantly higher technical success (93.7 % vs 77.2 %, P = 0.007) whilst clinical success as per intention to treat were similar. The mean (S.D.) procedural time was also significantly faster in the ECDS arm [15.57 (15.91) vs 670 28.67 (18.89) minutes, P < 0.001]. Whilst no difference in hospital stay (6 IQR (2-10) vs 4.5 (IQR 1 – 10) days, P = 0.272), 30-day adverse events rates (19.2 % vs 17.6 %, P = 0.812), 30-day mortality rates (5.1 % vs 6.5 %, P = 0.744) and 1-year stent dysfunction rates (8.9 % vs 8.9 %, P = 1) were observed.

Conclusions ECDS is associated with some advantages over ERCP in drainage of unresecetable malignant distal CBD obstruction. The procedure should be considered an option as the primary drainage procedure for these patients.

Citation: Teoh A, Napoleon B, Kunda R et al. OP93 EUS-GUIDED CHOLEDOCHO-DUODENOSTOMY VERSUS ERCP WITH COVERED METALLIC STENTS IN PATIENTS WITH UNRESECTABLE MALIGNANT DISTAL BILIARY OBSTRUCTION. A MULTI-CENTERED RANDOMIZED CONTROLLED TRIAL (DRA-MBO TRIAL). Endoscopy 2021; 53: S39.

Publication History

Article published online:
19 March 2021