Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

Descriptive Information
Brief Title † Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
Official Title † Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis
Brief Summary Only a small proportion of patients with biliary obstruction caused by hepatopancreatobiliary malignancies are suitable for surgical resection. Therefore, most patients with malignant biliary obstruction will need palliation of their obstructive jaundice to relieve the symptoms and prevent life threatening complications such as biliary sepsis. The endoscopic or percutaneous/transhepatic routes, such as endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic cholangiography (PTC), and stents are accepted approaches for the relief of jaundice in malignant biliary obstruction. Improvement in the bilirubin level is also essential before palliative chemotherapy is considered in these patients. However, tumor ingrowth still remains a major cause of obstruction. In this trial, the investigators will use HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for the endobiliary radiofrequency ablation (RFA) treatment as a form of neoadjuvant therapy in hepatopancreatobiliary adenocarcinoma.
Detailed Description The HabibTM EndoHPB (EMcision Ltd., UK) catheter which was used for the endobiliary radiofrequency ablation (RFA) treatment is an endoscopic bipolar catheter designed to ablate tissue in malignant tumors within luminal structures. HabibTM EndoHPB has Food and Drug Administration (FDA) and European Conformity approval for such indications. It has also approved by Ministry of Health and Welfare in 2016. In this study, the investigators will perform intra-luminal RFA for 20 inoperable patients with malignant biliary stenosis. HabibTM EndoHPB will be deployed via an endoscopic retrograde cholangiopancreatography (ERCP) route. By using radiofrequency energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes occluded. If stent occlusion occurs in a participant during the follow up period, the participant will be reassessed and investigations will be used to determine cause of stent occlusion and whether it is appropriate to repeat RFA treatment. The aim will be to detect an improvement in survival and safety in the treated patients compared to patient receiving palliative treatment recorded in literatures.
Study Phase N/A
Study Type † Interventional
Study Design †
Primary Outcome Measure † survival benefit
Secondary Outcome Measure † the recurrence of bile duct obstruction and jaundice
Condition † Liver Cancer Bile Duct Cancer Pancreatic Cancer
Intervention † Device'Intra-luminal radiofrequency ablation (Habib EndoHPB)
Study Arms / Comparison Groups Intra-luminal radiofrequency ablation Intra-luminal radiofrequency ablation Admission for endoscopic retrograde cholangiopancreatography (ERCP) and stent placement after radiofrequency ablation. ERCP should be performed for 2 times with an interval of two months.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 20
Start Date † June 2016
Completion Date May 2018
Primary Completion Date May 2018
Eligibility Criteria † Inclusion Criteria: - Patients must meet all of the following inclusion criteria to be eligible for this study: 1. 20 Years and older. 2. The diagnosis of hepatopancreaticobiliary cancers with pathologic proven, and the diagnosis of hepatopancreaticobiliary cancers will be made by pathology / cytology or according to the American Association for the Study of Liver Diseases (AASLD) (2010) diagnostic criteria. 3. Participant unsuitable for surgical resection. Criteria for unresectability being based on metastatic disease or locally advanced. 4. Eastern Cooperative Oncology Group (ECOG) score of 0-1. 5. American Society of Anaesthesiologists (ASA) score ≤ 3. 6. Karnofsky score >30. 7. Jaundice (bilirubin level over 10 mg/dL). Alanine transaminase (ALT) and aspartate transaminase (AST)
Gender All
Ages 20 Years - 75 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT02841800
Organization ID 201604030DIPD
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † National Taiwan University Hospital
Collaborators ††
Investigators † Principal Investigator: Kai-Wen Huang, MD, PhD, National Taiwan University Hospital
Information Provided By
Verification Date July 2016
First Received Date † July 19, 2016
Last Updated Date February 21, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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