CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 58 enrolled
Drug / intervention
Endoscopic radiofrequency ablation +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01758341
NCT01758341Phase 4Completed

Endoscopic Radiofrequency Ablation for Malignant Biliary Obstruction

Medical University of Vienna·interventional·Posted Jan 1, 2013·Updated Jan 23, 2014

In Brief

A Phase 4 clinical trial evaluating Endoscopic radiofrequency ablation, Endoscopic retrograde cholangiopancreatography (ERCP), and 1 other intervention for Biliary Tract Neoplasms. Completed, enrolled 58 participants across 1 site.

Detailed Summary

Biliary obstruction is importantly influencing quality of life and survival of patients suffering from primary or secondary bile duct malignancies. The aim of this retrospective data analysis is to evaluate endoscopic radiofrequency ablation (RFA) with the HabibTM EndoHBP catheter for the treatment of malignant biliary obstruction. RFA procedures performed in Austria so far will be analyzed with regard to feasibility and safety of the technique. Therefore, the following parameters will be assessed: (among others) technical failures during the RFA procedure, complications during the RFA procedure, hospital stay, adverse events during hospital stay and until first clinical control after discharge (an expected average of 4 weeks after RFA procedure), 30-day and 90-day mortality. The results of this study should help to better understand important aspects of biliary RFA which may positively influence future applications of this method.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 1, 2013
Enrollment StartDec 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.5 years ago

Interventions

Endoscopic radiofrequency ablationprocedure

Endoscopic radiofrequency ablation with the HabibTM EndoHBP catheter uses bipolar electrical energy for tissue coagulation and can be applied without any special patient preparation in the context of an endoscopic retrograde cholangiopancreatography (ERCP) examination to treat malignant biliary strictures.

Endoscopic retrograde cholangiopancreatography (ERCP)procedure

ERCP is used to guide the RFA-catheter under radiological control to the location of the malignant stricture.

HabibTM EndoHPB catheterdevice

Used to apply radiofrequency energy to the malignant biliary stricture (see also intervention "endoscopic radiofrequency ablation")