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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01303159
• Collaborator: EMcision Limited (Other)
• Enrollment: 29
• Location: 1
• Arm: 1
• Duration (Months): 46.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cholangiocarcinoma; Pancreatic Cancer	Device: Endoscopic bipolar radiofrequency probe (ENDOHPB)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jan 13, 2014
• Actual Study Completion Date: Jan 13, 2014

Arms and Interventions

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

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 Names: EndoHPB (EMcision Ltd, UK)

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Bile Duct Stricture Diameter [2 years]

   To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Secondary Outcome Measures

1. Number of Participants With Adverse Events [2 years]

   To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01303159
• Other Study ID Numbers: 1107011793
• First Posted: Feb 24, 2011
• Last Update Posted: May 23, 2017
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University: Cholangiocarcinoma; Pancreatic Cancer; Radiofrequency; Ablation
• Additional relevant MeSH terms: Pancreatic Neoplasms; Cholangiocarcinoma

Study Results

Participant Flow

Arm/Group Title	Radiofrequency Probe (ENDOHPB)
Arm/Group Description	Intervention: The EndoHPB Radiofrequency probe
Period Title: Overall Study
STARTED	29
COMPLETED	6
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Radiofrequency Probe (ENDOHPB)
Arm/Group Description	Intervention: The EndoHPB Radiofrequency probe
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69 (12.9)
Sex: Female, Male (Count of Participants)
Female	7 24.1%
Male	22 75.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Bile Duct Stricture Diameter
Description	To assess effectiveness of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Participants not analyzed has study was terminated before follow up data could be collected.

Arm/Group Title	Radiofrequency Probe (ENDOHPB)
Arm/Group Description	Intervention: The EndoHPB Radiofrequency probe
Measure Participants	0
	0

2. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Preliminary analyses because study was terminated before follow up data could be collected.

Arm/Group Title	Radiofrequency Probe (ENDOHPB)
Arm/Group Description	Intervention: The EndoHPB Radiofrequency probe
Measure Participants	29
Number [participants]	16 55.2%

Adverse Events

Time Frame	6 months
Arm/Group Title	Radiofrequency Probe (ENDOHPB)
Arm/Group Description	Intervention: The EndoHPB Radiofrequency probe
All Cause Mortality
	Radiofrequency Probe (ENDOHPB)
	Affected / at Risk (%)	# Events
Total	16/29 (55.2%)
Serious Adverse Events
	Radiofrequency Probe (ENDOHPB)
	Affected / at Risk (%)	# Events
Total	16/29 (55.2%)
Gastrointestinal disorders
Fever	4/29 (13.8%)	4
Death	16/29 (55.2%)	16
Gastrointestinal Bleeding	1/29 (3.4%)	1
Cholecystitis	1/29 (3.4%)	1
Other (Not Including Serious) Adverse Events
	Radiofrequency Probe (ENDOHPB)
	Affected / at Risk (%)	# Events
Total	0/29 (0%)

Limitations/Caveats

Early study termination leading to no preliminary analyses. Total enrolled 29, only 6 subjects had follow up data of 6 months.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.