Digital single-operator cholangioscopy for difficult anastomotic biliary strictures in living donor liver transplant recipients after failure of standard ERCP: SPYPASS-2 study (with videos)

Background and aims: Liver transplantation (LT) is a curative treatment for end-stage liver disease. Anastomotic biliary strictures (ABSs) are more common in living donor LT (LDLT). However, the success rate of ERCP for ABS remains unsatisfactory. In this study, we evaluated 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; Boston Scientific Corp, Natick, Mass, USA) to treat ABSs when guidewire placement across the ABS was difficult during conventional ERCP (cannulation time >10 minutes) between October 2021 and May 2023. Our primary endpoint was technical success, defined as successful guidewire placement across the ABS and/or subsequent treatment. Secondary endpoints were rates of clinical success, adverse events, and reintervention.

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 success 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 1 month occurred in 2 patients (5.4%), and 4 patients (10.8%) required reintervention within 1 month.

Conclusions: This study shows the efficacy and safety of SOC-facilitated management for difficult ABSs in LDLT patients after failure of standard ERCP. (Clinical trial registration number: NCT05065125.).