Working… Menu

RFA for Malignant Biliary Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03166436
Recruitment Status : Unknown
Verified May 2017 by Tomas Hucl, Institute for Clinical and Experimental Medicine.
Recruitment status was:  Recruiting
First Posted : May 25, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
Tomas Hucl, Institute for Clinical and Experimental Medicine

Brief Summary:

Pancreatic cancer and cholangiocarcinoma are the most common causes of malignant biliary obstruction. They are diseases of increasing incidence and unfavorable prognosis. Only a minority of patients have a localized disease and are indicated for surgery with a chance of long-term survival. Locally advanced and metastatic tumors are treated with palliative chemotherapy or chemoradiotherapy; the results of such treatments are unsatisfactory. The average survival of patients with unresectable disease is 6 months and only 5 - 10 % of patients survive 5 years. Chemotherapy and radiotherapy can be used, however only with a palliative effect. Biliary drainage is an integral part of palliative treatment. Endoscopically or percutaneously placed stents improve quality of life, decrease cholestasis and pruritus, but do not significantly improve survival. Biliary stents get occluded over time, possibly resulting in acute cholangitis and require repeated replacement. Endoluminal biliary photodynamic therapy (PDT) and radiofrequency ablation (RFA), locally active endoscopic methods, have been increasingly used in recent years in palliative treatment of patients with malignant biliary obstruction. In photodynamic therapy, improved survival has been shown in two randomized controlled trials; however the technique suffers from technical complexity, high cost and low availability. In RFA, application of low voltage high frequency current during radiofrequency ablation results in tissue destruction by heat. Its antitumor effect may also be related to systemic changes in antitumor immunity. The use of endoluminal biliary RFA has so far been reported only in small retrospective cohorts of patients.

The aim of this randomized study is to compare efficacy of RFA plus stenting to stenting alone in palliative treatment of malignant biliary obstruction with survival as primary outcome. Secondary outcomes are stent patency, immediate and late complications, quality of life and effects on anti-tumor immunity in the RFA group.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Pancreas Cancer Procedure: Radiofrequency ablation Procedure: Biliary stenting Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation Plus Stenting Versus Stenting Alone for Treatment of Malignant Biliary Obstruction
Estimated Study Start Date : June 8, 2017
Estimated Primary Completion Date : May 8, 2019
Estimated Study Completion Date : May 8, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RFA plus stenting
Endoluminal radiofrequency ablation followed by biliary stenting
Procedure: Radiofrequency ablation
radiofrequency ablation

Procedure: Biliary stenting
biliary stenting

Active Comparator: Stenting alone
Biliary stenting alone
Procedure: Biliary stenting
biliary stenting

Primary Outcome Measures :
  1. Survival [ Time Frame: 12 months ]
    number of days/months of survival (being alive) post intervention

Secondary Outcome Measures :
  1. Stent patency [ Time Frame: 12 months ]
    number of days/months of patent stent (not occluded) post intervention

  2. Complications [ Time Frame: 30 days ]
    number of complications related to procedure (bleeding, perforation, cholangitis will be combined to report as a complication)

  3. Quality of life [ Time Frame: 12 months ]
    validated questionnaire investigating quality of live post intervention

  4. Augmentation of antitumor immunity [ Time Frame: 30 days ]
    serum level of HSP 70 and selected cytokines will be measured from blood

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age over 18
  • Pathologically confirmed malignant bile duct obstruction (cholangiocarcinoma or pancreatic cancer)
  • Laboratory signs of biliary obstruction
  • Non-resectable disease (distant metastasis, locally advanced disease, patient related factors) based on a multidisciplinary team decision
  • Capability of giving informed consent
  • Life expectancy greater than 3 months

Exclusion Criteria:

  • Unstable for ERC
  • Inability to give informed consent
  • Pregnancy
  • Uncorrected coagulopathy
  • Concomitant biliary oncological endoluminal therapy (photodynamic therapy, brachytherapy)
  • Cardiac pacemaker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03166436

Layout table for location contacts
Contact: Tomas Hucl, MD, PhD 00420261362600
Contact: Petra Truxova, Ing 00420261362619

Layout table for location information
Department of Gastroenterology and Hepatology Recruiting
Prague, Czechia, 14021
Contact: Tomas Hucl, MD, PhD    00420261362600   
Contact: Petra Truxova, Ing    00420261362619   
Sponsors and Collaborators
Institute for Clinical and Experimental Medicine
Layout table for investigator information
Principal Investigator: Tomas Hucl, MD, PhD Institute for Clinical and Experimental Medicine

Layout table for additonal information
Responsible Party: Tomas Hucl, Vice-chairman, Department of Gastroenterology and Hepatology, Institute for Clinical and Experimental Medicine Identifier: NCT03166436    
Other Study ID Numbers: IKEM RFA CCA PC
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases