Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

February 25, 2013 updated by: Huihong Liang, Guangzhou Medical University

A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma

The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huihong Liang, MD
  • Phone Number: +86-20-34153043
  • Email: beanth@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Not yet recruiting
        • The second hospital of Guangzhou Medical college
        • Contact:
          • Huihong Liang, MD
          • Phone Number: +86-188-2648-8232
          • Email: beanth@163.com
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • The second hospital of Guangzhou Medical college
        • Contact:
          • Huihong Liang, Doctorial
          • Phone Number: +86-188-2648-8232
          • Email: beanth@163.com
        • Principal Investigator:
          • Huihong Liang, Doctoral

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Pathologically or radiologically confirmed biliary malignant
  • Inoperability by staging

Exclusion Criteria:

  • Cholangiocarcinoma with widespread metastasis
  • Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
  • Prior SEMS placement
  • Pregnancy
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
  • Life expectancy < 3months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self expanding metallic stent （SEMS ）placement only
Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
Procedure: Self expanding metallic stent (SEMS)
Self expanding metallic stent
Experimental: Endoscopic radiofrequency ablation plus SEMS
Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) would be performed to confirm the position and length of the biliary malignant. The radiofrequency ablation (RFA) catheter (EMcision, London, United Kingdom) would be placed under fluoroscopic guidance across the biliary stricture. Radiofrequency energy will be delivered to the malignant site. After that,A self expanding metallic stent (SEMS) would be placed to bypass the site of narrowing
Procedure: Self expanding metallic stent (SEMS)
Self expanding metallic stent
Procedure: Endoscopic radiofrequency ablation (ERFA)
Endoscopic radiofrequency ablation
Experimental: Photodynamic therapy plus SEMS
Photofrin is injected 3 days prior to laser activation of the agent.Endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) will be carried out to determine the length and positon of the biliary malignant. Delivery Fiber used along with the laser system to activate the photosensitizing agent and induce tumor tissue necrosis. A self expanding metallic stent (SEMS) will be placed the site of biliary narrowing
Procedure: Self expanding metallic stent (SEMS)
Self expanding metallic stent
Procedure: Photodynamic therapy (PDT)
Photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
stent patency
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Estimate)

February 26, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFA2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangiocarcinoma

Clinical Trials on Self expanding metallic stent (SEMS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe