- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01739465
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
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
-
-
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
|
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
|
Self expanding metallic stent
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
|
Self expanding metallic stent
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
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
-
Mayo ClinicNational Cancer Institute (NCI)Not yet recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic Cholangiocarcinoma | Oligometastatic Intrahepatic CholangiocarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Metastatic Intrahepatic Cholangiocarcinoma | Locally Advanced Intrahepatic CholangiocarcinomaUnited States
-
RedHill Biopharma LimitedCompletedCholangiocarcinoma | Cholangiocarcinoma Non-resectable | Cholangiocarcinoma, Perihilar | Cholangiocarcinoma, Extrahepatic | Cholangiocarcinoma, IntrahepaticUnited States
-
RedHill Biopharma LimitedAvailableCholangiocarcinoma | Cholangiocarcinoma Non-resectable | Cholangiocarcinoma, Perihilar | Cholangiocarcinoma, Extrahepatic | Cholangiocarcinoma, Intrahepatic
-
University of Kansas Medical CenterNational Cancer Institute (NCI)RecruitingStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Metastatic Cholangiocarcinoma | Locally Advanced Cholangiocarcinoma | Stage III Hilar Cholangiocarcinoma AJCC v8 | Stage IV Hilar Cholangiocarcinoma AJCC v8 | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Recurrent CholangiocarcinomaUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH); CelgeneActive, not recruitingResectable Cholangiocarcinoma | Stage IB Intrahepatic Cholangiocarcinoma AJCC v8 | Stage II Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIA Intrahepatic Cholangiocarcinoma AJCC v8 | Stage IIIB Intrahepatic Cholangiocarcinoma AJCC v8United States
-
National Cancer Institute (NCI)CompletedStage III Intrahepatic Cholangiocarcinoma AJCC v8 | Gallbladder Carcinoma | Metastatic Cholangiocarcinoma | Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 | Unresectable CholangiocarcinomaUnited States
-
Emory UniversityNational Cancer Institute (NCI)WithdrawnStage II Intrahepatic Cholangiocarcinoma AJCC v8 | Stage III Intrahepatic Cholangiocarcinoma AJCC v8 | Resectable Intrahepatic Cholangiocarcinoma | Stage 0 Intrahepatic Cholangiocarcinoma AJCC v8 | Stage I Intrahepatic Cholangiocarcinoma AJCC v8United States
-
AIO-Studien-gGmbHServierCompletedCholangiocarcinoma Non-resectable | Cholangiocarcinoma of the Gallbladder | Cholangiocarcinoma Metastatic | Cholangiocarcinoma AdvancedGermany
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingMetastatic Cholangiocarcinoma | Unresectable Cholangiocarcinoma | Advanced CholangiocarcinomaUnited States
Clinical Trials on Self expanding metallic stent (SEMS)
-
University of Cape TownUnknownRandomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant JaundiceBiliary ObstructionSouth Africa
-
Grupo Espanol de Trabajo en Enfermedad de Crohn...UnknownCrohn's Disease | Chronic Inflammation | StenosisSpain
-
University Hospital of CologneUniversitätsklinikum Hamburg-EppendorfNot yet recruitingLeaks, AnastomoticGermany
-
Sahlgrenska University Hospital, SwedenRecruitingDrainage | Pancreatic PseudocystSweden
-
Mayo ClinicWithdrawn
-
Vanderbilt University Medical CenterCompletedDistal Bile Duct ObstructionUnited States
-
University College, LondonBarts & The London NHS Trust; University Hospitals Bristol and Weston NHS Foundation... and other collaboratorsCompletedAcute Bleeding Esophageal VaricesUnited Kingdom
-
Asan Medical CenterCompletedCholestasis, ExtrahepaticKorea, Republic of
-
Beijing Chao Yang HospitalCompletedComplication of Treatment
-
Yonsei UniversityUnknownMalignant TumorKorea, Republic of