Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

This study is currently recruiting participants.
Verified February 2013 by Guangzhou Medical University
Sponsor:
Information provided by (Responsible Party):
Huihong Liang, Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01739465
First received: November 29, 2012
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Cholangiocarcinoma
Procedure: Self expanding metallic stent (SEMS)
Procedure: Endoscopic radiofrequency ablation (ERFA)
Procedure: Photodynamic therapy (PDT)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by Guangzhou Medical University:

Primary Outcome Measures:
  • stent patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739465

Contacts
Contact: Huihong Liang, MD +86-20-34153043 beanth@163.com

Locations
China, Guangdong
The Second Hospital of Guangzhou Medical College Not yet recruiting
Guangzhou, Guangdong, China, 510260
Contact: Huihong Liang, MD    +86-188-2648-8232    beanth@163.com   
The second hospital of Guangzhou Medical college Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Huihong Liang, Doctorial    +86-188-2648-8232    beanth@163.com   
Principal Investigator: Huihong Liang, Doctoral         
Sponsors and Collaborators
Guangzhou Medical University
  More Information

No publications provided

Responsible Party: Huihong Liang, Associated Professor, Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01739465     History of Changes
Other Study ID Numbers: RFA2012
Study First Received: November 29, 2012
Last Updated: February 25, 2013
Health Authority: China: Science and Technology Commission of Guangzhou

Keywords provided by Guangzhou Medical University:
Cholangiocarcinoma
Pathologic
Digestive System
Neoplasms
Neoplasms by Site
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases
Pathological Conditions
Constriction
Adenocarcinoma
Carcinoma

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014