Radiofrequency Ablation for Malignant Biliary Obstruction
This study is not yet open for participant recruitment.
Verified December 2012 by Medical University of Vienna
Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01758341
First received: December 11, 2012
Last updated: December 24, 2012
Last verified: December 2012
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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.
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758341
Contacts
| Contact: Werner Dolak, MD | 0043 1 40400 6589 | werner.dolak@meduniwien.ac.at |
| Contact: Andreas Puespoek, Prof | 0043 1 40400 4739 | andreas.puespoek@meduniwien.ac.at |
Locations
| Austria | |
| Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology | Not yet recruiting |
| Vienna, Austria | |
| Contact: Werner Dolak, MD 0043 1 40400 6589 werner.dolak@meduniwien.ac.at | |
| Contact: Andreas Puespoek, Prof. 0043 1 40400 4739 andreas.puespoek@meduniwien.ac.at | |
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: | December 24, 2012 |
| 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 Neoplasms Digestive System Neoplasms |
Neoplasms by Site Biliary Tract Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013