Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial
Jazyk angličtina Země Anglie, Velká Británie Médium electronic
Typ dokumentu randomizované kontrolované studie, časopisecké články, práce podpořená grantem
PubMed
37652677
DOI
10.1136/gutjnl-2023-329700
PII: gutjnl-2023-329700
Knihovny.cz E-zdroje
- Klíčová slova
- biliary obstruction, cholangiocarcinoma, pancreatic cancer, stents,
- MeSH
- cholangiokarcinom * MeSH
- cholestáza * etiologie chirurgie MeSH
- katetrizační ablace * škodlivé účinky metody MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory slinivky břišní * komplikace chirurgie MeSH
- nádory žlučových cest * komplikace chirurgie MeSH
- radiofrekvenční ablace * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stenty škodlivé účinky MeSH
- výsledek terapie MeSH
- žlučové cesty intrahepatální chirurgie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie 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.
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT03166436
