Transplant Trial Watch

Cost analysis of a long-term randomized controlled study in biliary duct-to-duct anastomotic stricture after liver transplantation.

Cantu, P., et al. (2021).

Transplant International [record in progress].


Aims
This study aimed to compare the effectiveness, treatment-related costs and adverse events of treating anastomotic stricture (AS) with fully covered self-expandable metal stents (FCSEMS) versus multiple plastic stent (MPS) following liver transplantation

Interventions
Patients were randomised to either the FCSEMS group or the MPS group.

Participants
30 liver transplant patients with duct-to-duct AS.

Outcomes
The outcomes of interest were treatment success, adverse events and a cost analysis. The cost analysis included the total cost of endoscopic therapy and hospitalisation for procedures and dealing with adverse events.

Follow-up
Median (range): 60 (34–80) months

CET Conclusions
This paper reports a cost-analysis from a randomised controlled trial in biliary stenting. Much of the crucial information about the study is written into a previous publication (Tal et al 2017) and not reproduced here. This paper represents the results of a subgroup of patients operated at one centre (30/58 patients). The study was previously assessed as being of good quality by our expert reviewer, although there was no blinding, which is a potential source of bias. Anastomotic strictures recurred in more metal-stent patients, with more stent migration than plastic-stent patients. This meant that, overall, there was a similar cost to achieve resolution of the condition in both arms, but the study was small and possibly underpowered.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
No

Trial registration
ClinicalTrials.gov - NCT01393067

Funding source
No funding received