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Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cholangiocarcinoma, Pancreatic Cancer

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Trial Information

Pilot Study to Assess Safety and Efficacy of an Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change from Baseline in Bile Duct Stricture Diameter

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Michel Kahaleh, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Institutional Review Board

Study ID:

14865

NCT ID:

NCT01303159

Start Date:

March 2010

Completion Date:

March 2014

Related Keywords:

  • Cholangiocarcinoma
  • Pancreatic Cancer
  • Cholangiocarcinoma
  • Pancreatic Cancer
  • Radiofrequency
  • Ablation
  • Pancreatic Neoplasms
  • Cholangiocarcinoma

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021