Endoscopic ultrasound-guided choledochoduodenostomy using a thin stent delivery system in patients with unresectable malignant distal biliary obstruction: a prospective multicenter study.

OBJECTIVES: When endoscopic retrograde cholangiopancreatography (ERCP) fails in patients with malignant distal biliary obstruction, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative. It associates with high technical and clinical success rates but also high adverse events rates. This prospective cohort study was aimed to evaluate the clinical efficacy and safety of EUS-CDS with our newly developed partially-covered self-expandable metal stent with a thin delivery system.

METHODS: The patients consisted of all consecutive patients in three tertiary referral centers with unresectable malignant distal obstruction in whom ERCP failed and in whom EUS-CDS with the thin delivery system was selected as the second-line approach. The rates of clinical success, technical success, technical success in cases not requiring fistulous tract dilation, adverse events, and stent dysfunction were determined.

RESULTS: In the 20 patients, the technical and clinical success rates were 95.0% (19/20) and 100% (19/19), respectively. In 31.6% (6/19), the delivery system was successfully inserted into the bile duct without requiring a fistulous-tract dilatation device. These patients had significantly shorter procedure times than patients requiring fistulous-tract dilatation (12.7±3.1 vs. 23.2±2.1 min; P<0.01). One patient (5.0%) who required fistulous dilation had an adverse event, which was managed conservatively. There were no procedure-related deaths. During follow-up, four patients (21.1%) developed stent dysfunction. Re-intervention was successful in all cases.

CONCLUSIONS: The EUS-CDS approach was associated with 95% technical and 100% clinical success rates, with adverse events reported in 5% of cases. EUS-CDS may become safer if efforts are made to avoid the dilation step (UMIN 000023938). This article is protected by copyright. All rights reserved.