Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study

期刊论文
发表日期：

2024年9月6日

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Nitin Jagtap,
C. Sai Kumar,
Sundeep Lakhtakia,
Mohan Ramchandani,
Sana Fathima Memon,
Shujaath Asif,
Rakesh Kalapala,
Zaheer Nabi,
Jahangeer Basha,
Rajesh Gupta,
Manu Tandan,
D. Nageshwar Reddy

摘要

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