06-09-2024 | Cholangiocarcinoma | Original Article
Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study
Published in: Indian Journal of Gastroenterology
Login to get accessAbstract
Introduction
The role of endo-biliary radio-frequency ablation (EB-RFA) in treating malignant biliary strictures remains a subject of controversy. This study aims to assess the efficacy and safety of EB-RFA in conjunction with self-expandable metal stents (SEMS) compared to SEMS alone.
Methods
This single-center prospective pragmatic comparative study, conducted between June 2021 and November 2022, involved 23 patients undergoing EB-RFA plus SEMS and 48 patients undergoing SEMS for unresectable malignant hilar obstruction. The study evaluated overall survival, stent patency and adverse events.
Results
Seventy-one patients (mean age [SD], 57.8 [11.2] years; 73.2% men) were enrolled. The clinical success rates did not significantly differ between the two groups (78.3% in EB-RFA and 66.6% in SEMS; p 0.316). The median (95% CI) overall survival was 155 (79.87–230.13) days in the EB-RFA group, contrasting with 86.0 (78.06–123.94) days in the SEMS group (p 0.020). The presence of carcinoma gallbladder (p 0.035; HR 0.55; 95% CI 0.32–0.96) and EB-RFA (p 0.047; HR 1.88; 95% CI 1.01–3.49) independently predicted overall survival. Median (95% CI) stent patency was 143.0 (95% CI, 61.61–224.39) days in the EB-RFA group compared to 78.0 (95% CI, 32.74–123.26) days in the SEMS group (p 0.019). The presence of carcinoma gallbladder (p 0.046, HR 0.60; 95% CI, 0.36–0.99), EB-RFA (p 0.023; HR 1.92; 95% CI, 1.10–3.36) and chemotherapy (p 0.017, HR 1.91; 95% CI, 1.12–3.26) independently predicted longer stent patency. There was no difference in procedure-related adverse events in both groups.
Conclusion
EB-RFA with SEMS placement proves to be a safe and effective technique for palliative biliary decompression in patients with malignant biliary strictures, demonstrating superior overall survival and stent patency compared to SEMS alone. Further confirmation through multi-center trials is warranted.
Clinical trial registration
ClinicalTrials.gov (ID: NCT05320328).
Graphical Abstract
×
![]()
