- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01303159
Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer
Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Only a small proportion of patients with biliary obstruction caused by cholangiocarcinoma or pancreatic cancer are suitable for surgical resection. As the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. Blocked drainage causes abdominal pain, bloating, and nausea. ERCP (endoscopic retrograde cholangiopancreatography) is often prescribed. ERCP with stent placement is the standard medical procedure for people with bile duct and pancreatic cancer.
The purpose of this study is to assess safety and ability of the endoscopic bipolar radiofrequency ablation (RFA) probe (ENDOHPB) to produce an improvement in the management of cancer of the bile duct or the pancreatic duct. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment. The study will look to see if the ENDOHPB is able to keep the stent open longer and perhaps decrease the number of invasive procedures for occluded (blocked) stents.
The objectives are:
• To assess assess the safety and effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Medical College of Cornell University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Either gender greater than or equal to 18 years of age.
- Pancreatic cancer or cholangiocarcinoma unsuitable for surgical resection. Criteria of unresectability being based on 1) metastatic disease or 2) locally advanced.
- Biliary obstruction
- Blocked self expanding mesh metal stent (SEMS)
- Subjects capable of giving informed consent
- Life expectancy of at least 3 months
Exclusion Criteria:
- Cardiac Pacemaker
- Patient unstable for endoscopy
- Inability to give informed consent
- Uncorrected coagulopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiofrequency probe (ENDOHPB)
Intervention: The EndoHPB is an endoscopic bipolar catheter designed to ablate tissue in malignant tumors within luminal structures, such as the biliary tree or pancreatic ducts. EndoHPB can be deployed via an ERCP or Percutaneous Transhepatic Cholangiographic (PTC) route. By using radiofrequency (RF) energy to heat the tissue in the duct prior to insertion of the stent, the surrounding tissue becomes coagulated and this may delay tumour growth and the time before the stent lumen becomes blocked. Thereby, allowing increased periods between the need for intervention and further stent deployment |
EndoHPB (EMcision Ltd, UK) is a single use sterile device for use at ERCP or PTC.
It is a 8F (2.6mm) catheter with a 1.8m working length, that is designed to be inserted into the target duct of the hepatic, biliary or pancreatic system over a guide wire.
The device is compatible with endoscopes that have a working channel of 3.2mm or greater.
It comprises of a coaxial over the wire (OTW) catheter with 2 ring electrodes spaced 8mm apart at its distal end.
The distal electrode is 5mm from the leading edge of the catheter.
The two electrodes at the distal end of EndoHPB are designed to produce a heating zone length of approximately 25 mm.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Bile Duct Stricture Diameter
Time Frame: 2 years
|
To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: 2 years
|
To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michel Kahaleh, M.D., Weill Medical College of Cornell University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1107011793
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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Ochsner Health SystemUnknown
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Weill Medical College of Cornell UniversityUnknownPancreatic Cancer | Cholangiocarcinoma | Bile Duct Cancer | Biliary Stricture | Bile Duct ObstructionUnited States
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Assiut UniversityNot yet recruitingOsteoarthritis, Knee
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Federal University of São PauloCompletedRadiation Injuries | TelangiectasisBrazil
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Trod Medical N.V.Unknown
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