Transplant Trial Watch

Intraductal Transanastomotic Stenting in Duct-to-Duct Biliary Reconstruction after Living Donor Liver Transplantation: A Randomized Trial.

Kumar KS, Shaji Mathew J, et al.

Journal of the American College of Surgeons 2017; 12: 12.

To study the impact of intraductal biliary stents on postoperative biliary complications after living-donor liver transplantation (LDLT).

Participants were randomised to receive either an intraductal stent, versus no stent.

64 patients aged >18 years of age undergoing LDLT.

The primary measued outcome was postoperative bile leak within 3 months of liver transplantation. Secondary outcomes measured included the occurrence of biliary strictures, postoperative hospital stay, postoperative culture (blood or bile) and interventions for biliary complications.

Median of 2 years

CET Conclusions
This is an interesting study that found strong evidence that the proposed treatment was harmful rather than beneficial. Unexpectedly the use of intra-ductal stents in live donor liver transplantation increased the risk of biliary leaks (36% versus 12%). A computer-generated randomisation sequence was used, and it was stratified to equally distribute livers with 2 ducts rather than 1 (livers with 3 ducts or more were excluded). The method of stenting was intra-ductal and trans-anastomotic. The study had been powered to show a reduction in biliary leak from 25% to 5%; to do this 124 patients were required. However, after the inclusion of 64 patients an interim analysis was done and the trial was stopped early due to the increased risk of bile leak. The authors found that bile leak was associated with an increased risk of biliary stricture. The authors speculated that the reason for the increased risk of bile leak was due to trauma caused during stent insertion.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration
Clinical Trials Registry of India - CTRI/2015/06/005950

Funding source
Not reported