Digital single-operator cholangioscopy for difficult anastomotic biliary strictures in living donor liver transplantation recipients after failure of standard ERCP: SPYPASS-2 study.

Background and aims: Liver transplantation (LT) is a curative treatment for end-stage liver disease. Anastomotic biliary strictures (ABS) are more common in living donor LT (LDLT). However, the success rate of endoscopic retrograde cholangiopancreatography (ERCP) for ABS remains unsatisfactory. This study aimed to evaluate the efficacy of single-operator cholangioscopy (SOC) for ABS treatment in LDLT recipients where standard ERCP failed to access the stricture.

Methods: This prospective study included 40 LDLT patients undergoing ERCP with SOC (SpyGlass™ DS II) to treat ABS when guidewire placement across the ABS was difficult during conventional ERCP (cannulation time >10 min) between October 2021 and May 2023. Our primary endpoint was technical success defined as successful guidewire placement across the ABS and/or subsequent treatment. The secondary endpoints were rates of clinical success, complication, and re-intervention.

Results: The mean patient age was 59.7 (±7.2) years, and the mean time from LDLT to the occurrence of ABS was 212 (±230) days. Technical and clinical successes were achieved in 92.5% (37/40) and 82.5% (33/40) of patients, respectively. The rates of post-ERCP cholangitis, pancreatitis, and bleeding were 10.0%, 15.0%, and 2.5%, respectively. Intestinal perforation did not occur, and all adverse events were mild in severity. Early stent migration within one month occurred in two (5.4%) patients, and four (10.8%) patients required re-intervention within one month.

Conclusions: This study shows the efficacy and safety of SOC-facilitated management for difficult ABS in LDLT patients after failure of standard ERCP.