Abstract
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).
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