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Sponsored by: |
Indiana University |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00578279 |
The purpose of this study is to obtain preliminary safety and efficacy data after EUS-CPN in patients with locally advanced or unresectable pancreatic adenocarcinoma.
Hypotheses:
Condition | Intervention | Phase |
---|---|---|
Pancreatic Cancer |
Drug: dehydrated alcohol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN) With Alcohol in Patients With Locally Advanced and Unresectable Pancreatic Adenocarcinoma: A Randomized Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A
subject randomized to 10ml of dehydrated alcohol
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Drug: dehydrated alcohol
subject randomized to 10ml ro 20ml of dehydrated alcohol one time during the EUS-CPN procedure
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B: Experimental
subject randomized to 20ml of dehydrated alcohol
|
Drug: dehydrated alcohol
subject randomized to 10ml ro 20ml of dehydrated alcohol one time during the EUS-CPN procedure
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must not have a coagulopathy (platelet <50,000, INR>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care.
Exclusion Criteria:
United States, Indiana | |
Clarian Health: Indiana University Hospital | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Julia LeBlanc, MD, MPH | Indiana University |
Responsible Party: | Indiana University Medical Center ( Dr. Julia LeBlanc ) |
Study ID Numbers: | 0702-25, IRB # 0702-25, Clarian Values Grant: vfr-262 |
Study First Received: | December 19, 2007 |
Last Updated: | August 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00578279 |
Health Authority: | United States: Institutional Review Board |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms |
Celiac Disease Endocrinopathy Adenocarcinoma Ethanol Endocrine Gland Neoplasms |
Anti-Infective Agents Anti-Infective Agents, Local Neoplasms Neoplasms by Site Therapeutic Uses |
Physiological Effects of Drugs Central Nervous System Depressants Central Nervous System Agents Pharmacologic Actions |