Radiofrequency Ablation for Malignant Biliary Obstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01758341
First received: December 11, 2012
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Biliary Tract Neoplasms
Procedure: Endoscopic radiofrequency ablation
Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)
Device: HabibTM EndoHPB catheter
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Radiofrequency Ablation for Malignant Biliary Obstruction

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Number of RFA-procedures with technical failures [ Time Frame: During the respective RFA-examination (an expected average of 1 hour) ] [ Designated as safety issue: No ]
    The technical feasibility in this study will be specified as ratio of all technically successful RFA-applications to all examinations in which RFA-use was intended. A RFA-application will be classified as technically successful if it is possible to introduce the RFA-catheter into the biliary system, place it adequately accross the malignant stricture, apply RFA-energy and withdraw the RFA-catheter after RFA-application.


Secondary Outcome Measures:
  • Number of patients with interventional complications [ Time Frame: During the respective RFA-procedure (an expected average of 1 hour) ] [ Designated as safety issue: Yes ]
    Clinically relevant complications occuring during the use of RFA, defined as any adverse change from the subject's baseline condition, which is considered to be clinically relevant by the physician, whether or not considered related to the medical device (e.g. bleeding, perforation).


Other Outcome Measures:
  • Hospital stay [ Time Frame: Inpatient stay after RFA-procedure (an expected average of 5 days) ] [ Designated as safety issue: No ]
    Duration of hospitalization after the performance of RFA.

  • Number of patients with Adverse events as a Measure of Safety and Tolerability [ Time Frame: During hospital stay and until first clinical control after discharge (an expected average of 4 weeks after RFA procedure) ] [ Designated as safety issue: Yes ]
    Adverse events occuring within 30 days after the RFA-procedure, defined as any adverse change from the subject's baseline condition, i.e. any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease which is considered to be clinically relevant by the physician, whether or not considered related to the medical device.

  • Mortality [ Time Frame: 30 days and 90 days after RFA-procedure (calculating 30- and 90-day mortality rate), assessed retrospectively by screening clinical reports (including death reports) of the study patients on average 1 year after RFA-procedure ] [ Designated as safety issue: Yes ]
    Deaths occuring within 30 and 90 days after the RFA-procedure.


Enrollment: 58
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Malignant biliary obstruction
All patients who underwent endoscopic radiofrequency ablation with the HabibTM EndoHBP as a treatment for malignant biliary obstruction in Austria between November 2010 and December 2012.
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")

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

All patients who underwent endoscopic radiofrequency ablation with the HabibTM EndoHBP as a treatment for malignant biliary obstruction in Austria between November 2010 and December 2012.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01758341

Locations
Austria
Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Werner Dolak, MD Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie
  More Information

Publications:

Responsible Party: Werner Dolak, MD, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01758341     History of Changes
Other Study ID Numbers: EK 1837/2012
Study First Received: December 11, 2012
Last Updated: January 22, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Malignant biliary obstruction
Endoscopic radiofrequency ablation
Therapeutic endoscopy

Additional relevant MeSH terms:
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014