Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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
| Estimated Enrollment: | 47 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 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 |
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| Contact: Michel Kahaleh, M.D. | 646-962-4797 | mkahaleh@gmail.com |
| Contact: Monica R Gaidhane, MPH | 646-962-4796 | mog2012@med.cornell.edu |
| United States, New York | |
| Weill Medical College of Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Michel Kahaleh, M.D. 646-962-4797 mkahaleh@gmail.com | |
| Contact: Monica Gaidhane, M.P.H 646-962-4796 mog2012@med.cornell.edu | |
| Principal Investigator: Michel Kahaleh, M.D. | |
| Principal Investigator: | Michel Kahaleh, M.D. | Weill Medical College of Cornell University |
More Information
No publications provided
| 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: | December 18, 2012 |
| 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 Diseases Pancreatic Neoplasms Cholangiocarcinoma Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms |
Digestive System Diseases Endocrine System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 22, 2013