Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

This study has been terminated.
(Treatment using the EndoHPB probe is FDA approved and considered standard of care.)
Sponsor:
Collaborator:
EMcision Limited
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01303159
First received: February 18, 2011
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Cholangiocarcinoma
Pancreatic Cancer
Device: Endoscopic bipolar radiofrequency probe (ENDOHPB)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Change from Baseline in Bile Duct Stricture Diameter [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer


Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer


Enrollment: 30
Study Start Date: March 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Device: Endoscopic bipolar radiofrequency probe (ENDOHPB)
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 Name: EndoHPB (EMcision Ltd, UK)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303159

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
EMcision Limited
Investigators
Principal Investigator: Michel Kahaleh, M.D. Weill Medical College of Cornell University
  More Information

Publications:
Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01303159     History of Changes
Other Study ID Numbers: 14865
Study First Received: February 18, 2011
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Cholangiocarcinoma
Pancreatic Cancer
Radiofrequency
Ablation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Cholangiocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 28, 2014