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 Vol. 44; no. 1; pp. 72 - 79
• Main Authors: Jagtap, Nitin, Kumar, C. Sai, Lakhtakia, Sundeep, Ramchandani, Mohan, Memon, Sana Fathima, Asif, Shujaath, Kalapala, Rakesh, Nabi, Zaheer, Basha, Jahangeer, Gupta, Rajesh, Tandan, Manu, Reddy, D. Nageshwar
• Format: Journal Article
• Language: English
• Published: New Delhi Springer India 01.02.2025; Springer Nature B.V
• Subjects: Ablation; Adult; Aged; Bile Duct Neoplasms - complications; Bile Duct Neoplasms - mortality; Bile Duct Neoplasms - surgery; Catheters; Chemotherapy; Cholangiocarcinoma; Cholestasis - etiology; Cholestasis - mortality; Cholestasis - surgery; Combined Modality Therapy; Constriction, Pathologic - etiology; Constriction, Pathologic - surgery; Electrodes; Endoscopy; Female; Gastroenterology; Hepatology; Humans; Jaundice; Male; Medical prognosis; Medicine; Medicine & Public Health; Middle Aged; Original Article; Pancreatitis; Patients; Prospective Studies; Radiofrequency Ablation - methods; Self Expandable Metallic Stents - adverse effects; Stents; Success; Survival analysis; Temperature; Treatment Outcome; Metal stent radiofrequency ablation; Survival; Cholangiocarcinoma hilar stricture
• ISSN: 0254-8860; 0975-0711; 0975-0711
• DOI: 10.1007/s12664-024-01668-1

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