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EUS-CPN in Unresectable Pancreatic Cancer: a Pilot Study

This study is ongoing, but not recruiting participants.

Sponsored by: Indiana University
Information provided by: Indiana University
ClinicalTrials.gov Identifier: NCT00578279
  Purpose

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:

  1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.
  2. Effective pain relief obtained from EUS-CPN will be related to better QOL

Condition Intervention Phase
Pancreatic Cancer
Drug: dehydrated alcohol
Phase IV

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

ChemIDplus related topics:   Ethanol   

U.S. FDA Resources

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

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Increased amounts of alcohol used in EUS-CPN is more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma. [ Time Frame: baseline, 24-hours after CPN, every week until the subject does not report pain relief ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increased amounts of alcohol used in EUS-CPN is safe in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma. [ Time Frame: 24-hours after procedure and every week until subject reports the CPN is no longer relieving pain ] [ Designated as safety issue: Yes ]
  • Effective pain relief obtained from EUS-CPN will be related to better QOL [ Time Frame: baseline, at 2 weeks, 4 weeks and every 4 weeks thereafter until subject is no longer in the study ] [ Designated as safety issue: No ]

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
Drug: dehydrated alcohol
subject randomized to 10ml ro 20ml of dehydrated alcohol one time during the EUS-CPN procedure
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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • A total of 20 consecutive subjects with locally advanced or unresectable pancreatic adenocarcinoma (stage II to IV) with pain (abdominal and/or back). Subjects with known or suspected unresectable pancreatic adenocarcinoma will be recruited for this study, as a diagnosis of unresectable pancreatic adenocarcinoma is often made during the endoscopic ultrasound (EUS) procedure.
  • Subjects must have documented disease by CT, ERCP, or EUS.
  • Subjects undergoing EUS for pancreatic cancer staging.
  • Subjects undergoing pancreatic cancer surgery are eligible for study entry beginning 5 days after the operation if they have not had an intraoperative celiac plexus neurolysis.
  • No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.

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.

  • Subjects must provide signed written informed consent.
  • A baseline pain score is not required, however, subjects must be having pain that is requiring a stable dose of pain medication for control of pain.

Exclusion Criteria:

  • Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical).
  • Presence of an implanted epidural or intrathecal analgesic therapy. Subjects with psychiatric illness that affects their ability to assess quality of life or compliance with the protocol.
  • Subjects with uncorrectable coagulopathy
  • Subjects with an allergy to bupivacaine or alcohol.
  • Presence of an aneurysm in the abdominal aorta, celiac trunk, or superior mesenteric artery.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578279

Locations
United States, Indiana
Clarian Health: Indiana University Hospital    
      Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators
Indiana University

Investigators
Principal Investigator:     Julia LeBlanc, MD, MPH     Indiana University    
  More Information


Responsible Party:   Indiana University Medical Center ( Dr. Julia LeBlanc )
Study ID Numbers:   0702-25, IRB # 0702-25, Clarian Values Grant: vfr-262
First Received:   December 19, 2007
Last Updated:   August 7, 2008
ClinicalTrials.gov Identifier:   NCT00578279
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Celiac Disease
Endocrinopathy
Adenocarcinoma
Ethanol
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on October 10, 2008




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