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Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT01739465
Recruitment Status : Unknown
Verified February 2013 by Huihong Liang, Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : December 3, 2012
Last Update Posted : February 26, 2013
Sponsor:
Information provided by (Responsible Party):
Huihong Liang, Guangzhou Medical University

Study Description
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Brief Summary:
The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
Study Start Date : November 2012
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. stent patency [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. overall survival rate [ Time Frame: 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01739465


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

Locations
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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
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Responsible Party: Huihong Liang, Associated Professor, Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01739465    
Other Study ID Numbers: RFA2012
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013
Keywords provided by Huihong Liang, 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:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms