Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial
Language English Country England, Great Britain Media electronic
Document type Randomized Controlled Trial, Journal Article, Research Support, Non-U.S. Gov't
PubMed
37652677
DOI
10.1136/gutjnl-2023-329700
PII: gutjnl-2023-329700
Knihovny.cz E-resources
- Keywords
- biliary obstruction, cholangiocarcinoma, pancreatic cancer, stents,
- MeSH
- Cholangiocarcinoma * MeSH
- Cholestasis * etiology surgery MeSH
- Catheter Ablation * adverse effects methods MeSH
- Quality of Life MeSH
- Middle Aged MeSH
- Humans MeSH
- Pancreatic Neoplasms * complications surgery MeSH
- Bile Duct Neoplasms * complications surgery MeSH
- Radiofrequency Ablation * MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Stents adverse effects MeSH
- Treatment Outcome MeSH
- Bile Ducts, Intrahepatic surgery MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Endoluminal radiofrequency ablation (RFA) has been promoted as palliative treatment for patients with cholangiocarcinoma (CCA) and pancreatic ductal adenocarcinoma (PDAC) in order to improve biliary drainage and eventually prolong survival. No high level evidence is, however, available on this technique. DESIGN: In this randomised controlled study, we compared endoluminal RFA plus stenting with stenting alone (control group) in patients with malignant biliary obstruction; metal stents were primarily placed. Primary outcome was overall survival; secondary outcomes were stent patency, quality of life and adverse events. In a superiority design, survival was assumed to be doubled by RFA as compared with 6.4 months in the control group (n=280). RESULTS: A total of 161 patients (male:female 90:71, mean age 71±9 years) were randomised before recruitment was terminated for futility after an interim analysis. Eighty-five patients had CCA (73 hilar, 12 distal) and 76 had pancreatic cancer. There was no difference in survival in both subgroups: for patients with CCA, median survival was 10.5 months (95% CI 6.7 to 18.3) in the RFA group vs 10.6 months (95% CI 9.0 to 24.8), p=0.58)) in the control group. In the subgroup with pancreatic cancer, median survival was 6.4 months (95% CI 4.3 to 9.7) for the RFA vs 7.7 months (95% CI 5.6 to 11.3), p=0.73) for the control group. No benefit was seen in the RFA group with regard to stent patency (at 12 months 40% vs 36% in CCA and 66% vs 65% in PDAC), and quality of life was unchanged by either treatment and comparable between the groups. Adverse events occurred in seven patients in each groups. CONCLUSION: A combination of endoluminal RFA and stenting was not superior to stenting alone in prolonging survival or improving stent patency in patients with malignant biliary obstruction. TRIAL REGISTRATION NUMBER: NCT03166436.
References provided by Crossref.org
ClinicalTrials.gov
NCT03166436
