Clinical Trial: Radiofrequency Ablation for Biliopancreatic Malignancy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Investigation of the Effect of Intraductal Radiofrequency Ablation in Inoperable Biliopancreatic Tumors Complicated With Obstructive Jaundice

Brief Summary: This phase-2 study aims to evaluate feasibility, safety and efficacy of thermal ablation of biliary obstructive malignancies by means of radiofrequency ablation (RFA, ELRA, StarMed) during endoscopic retrograde cholangio-pancreaticography (ERCP) with primary intent to obtain palliative biliary drainage via stenting

Detailed Summary:

INTRODUCTION

Biliary obstruction is the most relevant factor for survival and quality of life in patients suffering from primary bile duct malignancies or pancreatic head carcinoma. Due to their insidious course, these cancers are often diagnosed at an advanced stage. Thus, therapy is frequently restricted to palliative management. Within this setting, the prevention/treatment of biliary complications such as jaundice, cholangitis, or sepsis is one of the key therapeutic factors to extend survival and maintain quality of life (1-3). Endoscopic stenting of the biliary tract is now generally accepted as the primary approach to reestablish sufficient biliary drainage, provided approximately 50% of the liver parenchyma is drained (4). As the tumor grows, unfortunately, it often occurs that jaundice reappears despite primary stenting. Most oftenly this relates to unbridled tumor expansion leading to either stent-dysfunction by tumor ingrowth (through the mesh in case of metallic stenting of or via clogging of plastic stents) or either to extension in more proximal bile ducts/branches shutting of sufficient/adequate biliary drainage.

Given the context of incurable disease, a minimally-invasive strategy that could reduce the tumor burden in addition to stenting might be considered beneficial in terms of longer sustained bile duct drainage, and as such improve quality of life, more efficiently administered and better tolerated courses chemotherapy and delayed disease progression.

An example of such a potential minimal invasive strategy is RadioFrequency Ablation (RFA). It involves a modified electrocautery technique that has emerged among the many choices for local, minimally invasive tissue ablation. It has proven effective, versatile, and relatively inexpensive. RFA has been used
Sponsor: Universitaire Ziekenhuizen Leuven

Current Primary Outcome: Feasibility (ratio of technically successful RFA-applications to all examinations in which RFA-use was intended) [ Time Frame: 90 days after index procedure ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Efficacy measured by progression-free survival at 3 months upon standard follow-up imaging study and duration of stent patency (days) after the RFA-performed procedure [ Time Frame: 90 days after index procedure ]
  • 30-day-, 90-day and overall mortality [ Time Frame: 90 days after index procedure ]
  • Number of days and reasons for hospitalizations during the study period [ Time Frame: 90 day after index procedure ]
  • Quality of life (QuoL) by means of the EORTC QLQ-C15-PAL questionnaire after the procedure and at 30 and 90 days vs before [ Time Frame: 90 days after index procedure ]
  • safety (number and type of adverse events) [ Time Frame: 90 days after index procedure ]


Original Secondary Outcome: Same as current

Information By: Universitaire Ziekenhuizen Leuven

Dates:
Date Received: January 5, 2015
Date Started: November 2014
Date Completion:
Last Updated: May 10, 2016
Last Verified: November 2014