Clinical Trial: Intra-luminal Radiofrequency Ablation for Inoperable Malignant Biliary Stenosis

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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 Summary: 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.
Sponsor: National Taiwan University Hospital

Current Primary Outcome: survival benefit [ Time Frame: up to one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• the recurrence of bile duct obstruction and jaundice [ Time Frame: up to 3 years ]
  To analyze the recurrence of bile duct obstruction and jaundice.
• potential treatment-related complications [ Time Frame: up to 3 years ]
  To analyze potential treatment-related complications
• repeated biliary interventions [ Time Frame: up to 3 years ]
  To analyze the number of repeated biliary interventions

Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: July 19, 2016
Date Started: June 2016
Date Completion: May 2018
Last Updated: February 21, 2017
Last Verified: July 2016