Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04801719 |
| Other study ID # |
FNBKRNM0002 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 4, 2010 |
| Est. completion date |
December 31, 2019 |
Study information
| Verified date |
March 2021 |
| Source |
Brno University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The rationale of the study is to explore the safety and efficacy of endoluminal
radiofrequency ablation prior metal stent insertion in patiens with malignant biliary
stenosis.
Description:
The aim of this randomized study was to analyze survival rate in patients with malignant
biliary obstruction treated with metal stent insertion with or without previous endoluminal
radiofrequency ablation (RFA). Secondary endpoint was to analyze metal stent patency rate and
survival rate in the subgroup of infiltrative hilar cholangiocarcinomas standardly treated by
brachytherapy and metal stenting.
All patients underwent percutaneous cholangiography followed by transhepatic drainage, all
patients underwent histopathologic verification of the stenosis.
Randomised patients in selected arm received endoluminal RFA by 8F catheter (Habib™ EndoHPB;
EMcision Ltd., London, UK) before stenting procedure. Repeated ablations were processed
through stenotic areas (10W, 90-120s, Rita 1500, Angiodynamics Ltd), all drained biliary
tracts were used for introducing catheter and performance of ablation.
In experimental group ablation procedure was followed with uncovered self-expandable metal
stent insertion.
Brachytherapy procedure (performed in case of cholangiocarcinoma as institutional treatment
standard) was performed through 5F applicator by after loading system of iridium radiation
source (HDR brachytherapy, applicator temporarily placed into a drain for 3-4 days).
Prescribed dose was 15-24Gy at distance of 1.0cm in 3-4 fractions.
Analyzed characteristics:
Specific therapeutic procedures e.g. systemic chemotherapy, brachytherapy indicated by
multidisciplinary tumor board were recorded. Laboratory tests were evaluated withing 24 hours
before and after the RFA (AMS, INR, APTT, GMT, total bilirubin, ALP, ALT, AST). The time of
initial diagnosis, drainage procedures, ablation and stenting were referred to patient
survival. Patients underwent repeated ambulatory follow-up in 3months period (dedicated
ultrasound performed by interventional radiologist, in case of bilirubin and obstructive
enzymes elevation intensified follow up was performed). Patients time of death was gathered
from record of central database of insured persons or from hospital information system.
Procedural complications were graded in consensus by interventional radiologists and
oncologist according to Common Terminology Criteria for Adverse Events.
Primary stent patency:
Stent patency was defined as the duration from the insertion of the stent until the date of
closure. If the cause of death was directly related to stent failure, the date of death was
defined as time of stent closure. If no stent failure occurred (i.e. the absence of increased
total serum bilirubin levels or the absence of dilation of intrahepatic bile ducts on CT or
US examination even if total serum bilirubin level was increased), stent patency was
considered as censored at the date of death or at the end of the study period.
Statistical methods:
Analyses were performed using IBM SPSS Statistics 23 (IBM Corporation, Armonk, NY, USA).
Basic characteristics were summarized by absolute and relative frequencies and compared using
Fisher's exact test (categorical variables), continuous characteristics compared using the
Mann-Whitney test. Survival parameters were evaluated by Kaplan-Meier methodology,
differences in survival were evaluated by log-rank test. Relationships between survival
parameters and endoluminal biliary pathway ablation prior to stent insertion were modelled
using one-dimensional Cox regression models and described using a risk ratio (HR) of 95% CI
for HR and a p-value corresponding to the relevant regression coefficient. The level of
statistical significance in all analyses was set at α = 0.05.
