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Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Self expanding metallic stent (SEMS)
Endoscopic radiofrequency ablation (ERFA)
Photodynamic therapy (PDT)
Sponsored by
Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma, Pathologic, Digestive System, Neoplasms, Neoplasms by Site, Digestive System Diseases, Bile Duct Diseases, Biliary Tract Diseases, Pathological Conditions, Constriction, Adenocarcinoma, Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Hospital of Guangzhou Medical College
  • The second hospital of Guangzhou Medical collegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Self expanding metallic stent （SEMS ）placement only

Endoscopic radiofrequency ablation plus SEMS

Photodynamic therapy plus SEMS

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

stent patency

Secondary Outcome Measures

overall survival rate

Full Information

First Posted
November 29, 2012
Last Updated
February 25, 2013
Sponsor
Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01739465
Brief Title
Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma
Official Title
A Randomized Controlled Trial Comparing Endoscopic Biliary Radiofrequency Ablation With Photodynamic Therapy for Inoperable Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Medical University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
Cholangiocarcinoma, Pathologic, Digestive System, Neoplasms, Neoplasms by Site, Digestive System Diseases, Bile Duct Diseases, Biliary Tract Diseases, Pathological Conditions, Constriction, Adenocarcinoma, Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self expanding metallic stent （SEMS ）placement only
Arm Type
Active Comparator
Arm Description
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
Arm Title
Endoscopic radiofrequency ablation plus SEMS
Arm Type
Experimental
Arm Description
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
Arm Title
Photodynamic therapy plus SEMS
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Self expanding metallic stent (SEMS)
Intervention Description
Self expanding metallic stent
Intervention Type
Procedure
Intervention Name(s)
Endoscopic radiofrequency ablation (ERFA)
Intervention Description
Endoscopic radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy (PDT)
Intervention Description
Photodynamic therapy
Primary Outcome Measure Information:
Title
stent patency
Time Frame
6 months
Secondary Outcome Measure Information:
Title
overall survival rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huihong Liang, MD
Phone
+86-20-34153043
Email
beanth@163.com
Facility Information:
Facility Name
The Second Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihong Liang, MD
Phone
+86-188-2648-8232
Email
beanth@163.com
Facility Name
The second hospital of Guangzhou Medical college
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihong Liang, Doctorial
Phone
+86-188-2648-8232
Email
beanth@163.com
First Name & Middle Initial & Last Name & Degree
Huihong Liang, Doctoral

12. IPD Sharing Statement

Learn more about this trial

Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

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