Radiofrequency Ablation for Malignant Biliary Obstruction
|ClinicalTrials.gov Identifier: NCT01758341|
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : January 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Neoplasms||Procedure: Endoscopic radiofrequency ablation Procedure: Endoscopic retrograde cholangiopancreatography (ERCP) Device: HabibTM EndoHPB catheter||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Radiofrequency Ablation for Malignant Biliary Obstruction|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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")
- Number of RFA-procedures with technical failures [ Time Frame: During the respective RFA-examination (an expected average of 1 hour) ]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.
- Number of patients with interventional complications [ Time Frame: During the respective RFA-procedure (an expected average of 1 hour) ]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).
- Hospital stay [ Time Frame: Inpatient stay after RFA-procedure (an expected average of 5 days) ]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) ]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 ]Deaths occuring within 30 and 90 days after the RFA-procedure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758341
|Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology|
|Principal Investigator:||Werner Dolak, MD||Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterologie and Hepatologie|