Pancreatic Cancer Clinical Trial
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
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.
Status | Terminated |
Enrollment | 30 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Weill Medical College of Cornell University | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | EMcision Limited |
United States,
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. 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Number of Participants with Adverse Events | To assess safety of an endoscopic bipolar radiofrequency catheter (EndoHPB) in the management of unresectable cholangiocarcinoma and pancreatic cancer | 2 years | Yes |
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