Endoscopic Radiofrequency Ablation for Malignant Biliary Obstruction
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Number of RFA-procedures with technical failures
Study Overview
Brief 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.
Detailed Description
Introduction
Biliary obstruction is the most relevant life limiting factor in patients suffering from primary or secondary bile duct malignancies. Underlying tumors, such as extrahepatic cholangiocarcinoma (CCa) of Klatskin type, pancreatic adenocarcinoma or metastases of colorectal cancer, are often diagnosed at an advanced stage when presenting with biliary obstruction. This mostly restricts treatment strategies to palliative management. Within this setting the prevention of biliary complications like jaundice, cholangitis or cholangiosepsis is one of the therapeutic key factors to extend survival and maintain quality of life [De Groen, Skipworth]. Endoscopic stenting of the biliary tract is an easy and safe approach to restore biliary drainage [Smith]. Self-expanding metal stents are preferred to plastic stents because of the lower risk of stent occlusion [Kaassis, Soderlund]. In addition to stenting endoscopic therapies that directly affect the local tumor mass, have been developed within the past years. First of all, photodynamic therapy using different photosensitizers has shown promising results for the reduction of tumor size and maintenance of biliary drainage [Ortner, Zoepf]. However, the patient management for this treatment involving peri-interventional photosensitivity remains cumbersome.
Recently, an endoscopically applicable radiofrequency catheter for the biliary tract, the so called HabibTM EndoHBP catheter, was introduced into the market. It 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. RFA is well known from transcutaneous applications, where it already proved to be effective as a treatment option for hepatocellular carcinoma or intrahepatic CCa [Minami]. The new HabibTM EndoHBP catheter was already evaluated ex vivo [Itoi] and showed promising results concerning safety and prevention of stent occlusion in the context of one small retrospective clinical study [Steel].
Primary objective
Feasibility and safety of endoscopic radiofrequency ablation with the HabibTM EndoHBP catheter for the treatment of malignant biliary obstruction
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of patients with interventional complications(During the respective RFA-procedure (an expected average of 1 hour))
Investigators
Werner Dolak, MD
Principal Investigator
Medical University of Vienna