BACKGROUND AND AIM: When endoscopic retrograde cholangiopancreatography (ERCP) fails in patients with malignant distal biliary obstruction, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative. It has high technical and clinical success rates, but also has high adverse event 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: 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. 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, 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. Reintervention was successful in all cases. CONCLUSIONS: The EUS-CDS approach had 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).
BACKGROUND AND AIM: When endoscopic retrograde cholangiopancreatography (ERCP) fails in patients with malignant distal biliary obstruction, endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) is an alternative. It has high technical and clinical success rates, but also has high adverse event 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: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. 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, 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. Reintervention was successful in all cases. CONCLUSIONS: The EUS-CDS approach had 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).