Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

New York Weill Cornell Cancer Center at Cornell University

Michel Kahaleh, M.D.

Principal Investigator

Michel Kahaleh, M.D.		Ph: 646-962-4797
		Email: mkahaleh@gmail.com

U.S.A.
New York
	New York
	New York Weill Cornell Cancer Center at Cornell University
		Michel Kahaleh, M.D.	Ph: 646-962-4797
			Email: mkahaleh@gmail.com
		Monica Gaidhane, M.P.H	Ph: 646-962-4796
			Email: mog2012@med.cornell.edu
		Michel Kahaleh, M.D.	Principal Investigator

See All Trial Sites

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01303159
Information obtained from ClinicalTrials.gov on December 19, 2012

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