Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F23%3A00084415" target="_blank" >RIV/00023001:_____/23:00084415 - isvavai.cz</a>

Alternative codes found

RIV/00064173:_____/23:43926003

Result on the web

<a href="https://gut.bmj.com/content/gutjnl/72/12/2286.full.pdf" target="_blank" >https://gut.bmj.com/content/gutjnl/72/12/2286.full.pdf</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/gutjnl-2023-329700" target="_blank" >10.1136/gutjnl-2023-329700</a>

Result language

angličtina

Original language name

Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial

Original language description

BackgroundEndoluminal 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.DesignIn 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).ResultsA total of 161 patients (male:female 90:71, mean age 71 &amp; PLUSMN;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.ConclusionA 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 numberNCT03166436.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30219 - Gastroenterology and hepatology

Project

<a href="/en/project/NV17-30281A" target="_blank" >NV17-30281A: Radiofrequency ablation in therapy of biliary and pancreatic disease</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2023

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Gut

ISSN

0017-5749

e-ISSN

1468-3288

Volume of the periodical

72

Issue of the periodical within the volume

12

Country of publishing house

GB - UNITED KINGDOM

Number of pages

8

Pages from-to

2286-2293

UT code for WoS article

001058398600001

EID of the result in the Scopus database

2-s2.0-85170670853