Clinical Trial: RFA RCT for Pancreatic or Bile Duct Cancer

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Controlled Trial Comparing Radiofrequency Ablation and Stenting vs. Stenting Alone for Biliary Obstruction Due to Unresectable Cholangiocarcinoma and Pancreatic Cancer

Brief Summary:

Malignant obstructive jaundice is a common complication of advanced stage pancreatic adenocarcinoma and cholangiocarcinoma. Over 50% of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis. Biliary drainage with placement of self-expanding metal stents (SEMSs) for palliation is the therapy of choice in this set of patients. Conventional stent placement provides palliation for a limited duration only and these subjects come back with obstructive jaundice. Due to age, comorbidities, malignant disease status, it is better to conduct reduced number of therapeutic endoscopies to reduce the number of complications. Additionally, only biliary stenting itself may provide only palliation, and not increase the duration of survival.

Currently, there are only two therapies. Recently, photodynamic therapy (PDT) has been evaluated as a palliative and potential neoadjuvant modality. Therefore if RFA confers similar benefits, then it may potentially be used as an alternative to PDT, given the lower adverse event profile. More recently, RFA has been recognized for its potential in palliative treatment of malignant biliary strictures. Based on the published data, RFA provides palliation and seems to increase survival duration in pancreatic cancer. Our own limited experience shows the same. The goal of this randomized controlled trial is to definitely confirm the benefit of Radiofrequency ablation (RFA) in providing increased survival time and quality of life in patients with non-resectable cholangiocarcinoma and pancreatic cancer. These benefits will improve clinical practice by making RFA the new standard of care for unresectable cholangiocarcinoma (CCA) and pancreatic cancer (PC). It will also enhance scientific knowledge by opening the door for new opportunities, e.g. RFA as a potential use for neoadjuvant the

Detailed Summary:

Pancreatic ductal adenocarcinoma (PC) is a deadly disease. It remains the fourth most common cause of death from cancer in the USA and one of the deadliest cancers in the world. Although treatments have improved, average PC 5-year survival is around 5%. Malignant obstructive jaundice is a common complication of advanced stage pancreatic adenocarcinoma. Over 50% of common bile duct (CBD) obstructions are due to malignancy, and the majority of neoplasms are unresectable at the time of diagnosis.

Biliary drainage with placement of self-expanding metal stents (SEMS) for palliation is the therapy of choice in this set of patients. Metal stenting results in biliary decompression in greater than 80% of cases with a lower complication rate than surgery. When compared to plastic stents, SEMSs present a significantly reduced risk of recurrent biliary obstruction. SEMSs are also more cost effective than plastic stents in patients with a life expectancy of longer than 4 months. Despite their numerous benefits, SEMS become occluded in up to 50% of patients in the first 6-8 months. Covered SEMSs are not resistant to tumor overgrowth or sludge formation and thus stent occlusion results in increased morbidity and mortality.

This relief is temporary since stents tend to become obstructed. More recently, RFA has been recognized for its potential in palliative treatment of malignant biliary strictures.

Photodynamic therapy (PDT) has been previously evaluated as a palliative and potential neoadjuvant modality in patients with biliary obstruction from cholangiocarcinoma. Therefore if RFA confers similar benefits, then it may potentially be used as in a similar manner to PDT, in addition given the lower adverse event profile, it may confer a greater patient tolerance. EndoHPB, the intervention a
Sponsor: Reem Z. Sharaiha

Current Primary Outcome: Clinical Success- composite [ Time Frame: 1 year ]

Clinical Success Composite of Stent patency, serum bilirubin and general quality of life measured at 3 months, 6 months, 9 months and 12 months as well as survival duration.


Original Primary Outcome: Same as current

Current Secondary Outcome: Mutational Profile of DNA post interventional procedure [ Time Frame: 1 year ]

Mutational profile of DNA using FISH (Fluorescence in situ hybridization) analysis on brushings of bile duct after RFA procedure to further understand the implications at the cellular and genetic level at 1 month, 3 months, 6 months, and 9 months


Original Secondary Outcome: Same as current

Information By: Weill Medical College of Cornell University

Dates:
Date Received: June 11, 2014
Date Started: June 2014
Date Completion: June 2017
Last Updated: June 2, 2015
Last Verified: June 2015