Prospective multicenter study of primary EUS-guided choledochoduodenostomy using a covered metal stent.

Background and Objectives: EUS-guided biliary drainage (EUS-BD) is increasingly reported as a salvage technique after failed endoscopic retrograde cholangiopancreatography, but it is still controversial whether EUS-BD can replace transpapillary biliary stenting. Therefore, we conducted this multicenter, prospective study of EUS-guided choledochoduodenostomy (EUS-CDS) using a covered metallic stent (CMS) as primary biliary drainage for unresectable distal malignant biliary obstruction (MBO).

Methods: Patients with unresectable distal MBO without any prior drainage are enrolled. Primary endpoint is a technical success and secondary endpoints are adverse events, functional success, and recurrent biliary obstruction (RBO) of EUS-CDS. Clinical outcomes were compared between EUS-CDS and transpapillary stenting as a control.

Results: A total of 34 patients were enrolled in 10 Japanese institutions. The cause of MBO was pancreatic cancer in 28 patients. Median tumor size and common bile duct diameter were 31 and 13 mm, respectively. Technical success rate was 97% with a median procedure time of 25 min and functional success rate was 100%. The rate of RBO was 29% and the causes of RBO were nontumor related: Migration in 18%, sludge/food impaction in 9%, and stent impaction to the duodenal wall in 3%. Other adverse events were abdominal pain in 6% and cholecystitis in 9%. A median cumulative time to RBO was 11.3 months. The rate of RBO and cumulative time to RBO of EUS-CDS were comparable to those of transpapillary stenting (36% and 9.1 months, respectively).

Conclusion: EUS-CDS using a CMS as primary biliary drainage was technically feasible and its safety appeared comparable to transpapillary stenting.