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Radiofrequency Ablation for Malignant Biliary Obstruction

NCT01758341 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-01-23

No results posted yet for this study

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.

Conditions

  • Biliary Tract Neoplasms

Interventions

PROCEDURE

Endoscopic radiofrequency ablation

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.

PROCEDURE

Endoscopic retrograde cholangiopancreatography (ERCP)

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

DEVICE

HabibTM EndoHPB catheter

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

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Werner Dolak, MD · Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01758341 on ClinicalTrials.gov