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

NCT01303159 | Terminated Results FDA Device

• 1 other identifier: 1107011793
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma; Pancreatic Cancer

Keywords

Cholangiocarcinoma; Pancreatic Cancer; Radiofrequency; Ablation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Bile Duct Stricture Diameter

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

  2 years

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  2 years

Study Arms (1)

Radiofrequency probe (ENDOHPB)

EXPERIMENTAL

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)

Interventions

Endoscopic bipolar radiofrequency probe (ENDOHPB) DEVICE

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.

Also known as: EndoHPB (EMcision Ltd, UK)

Radiofrequency probe (ENDOHPB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiac Pacemaker
• Patient unstable for endoscopy
• Inability to give informed consent
• Uncorrected coagulopathy

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• EMcision Limited: collaborator

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

• Figueroa-Barojas P, Bakhru MR, Habib NA, Ellen K, Millman J, Jamal-Kabani A, Gaidhane M, Kahaleh M. Safety and efficacy of radiofrequency ablation in the management of unresectable bile duct and pancreatic cancer: a novel palliation technique. J Oncol. 2013;2013:910897. doi: 10.1155/2013/910897. Epub 2013 Apr 8.

  PMID: 23690775 RESULT

MeSH Terms

Conditions

Cholangiocarcinoma; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Michel Kahaleh
• Organization: Weill Cornell Medical College

mik9071@med.cornell.edu

646-962-4797

Study Officials

• Michel Kahaleh, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Advanced Endoscopy

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 24, 2011
• Study Start: March 1, 2010
• Primary Completion: January 13, 2014
• Study Completion: January 13, 2014
• Last Updated: May 23, 2017
• Results First Posted: May 23, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)