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Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00578279
First Posted: December 21, 2007
Last Update Posted: October 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Indiana University
  Purpose

The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (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 quality of life (QOL)

Condition Intervention Phase
Pancreatic Cancer Drug: dehydrated alcohol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection [ Time Frame: baseline up to 1 year ]
    Pain will be assessed at baseline 24 hours after the procedure and weekly thereafter, until the subject reports no subjective pain relief from the procedure. Pain relief is defined as a decrease in 2 points on a 0-10 point pain rating scale. Zero is no pain and 10 is the worst pain.


Enrollment: 20
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (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 or 20ml of dehydrated alcohol one time during the EUS-CPN procedure
Experimental: B
subject randomized to 20ml of dehydrated alcohol
Drug: dehydrated alcohol
subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 computed tomography (CT), endoscopic retrograde cholangio-pancreatography (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00578279     History of Changes
Other Study ID Numbers: 0702-25
IRB # 0702-25
Clarian Values Grant: vfr-262
First Submitted: December 19, 2007
First Posted: December 21, 2007
Results First Submitted: September 23, 2010
Results First Posted: October 19, 2012
Last Update Posted: October 19, 2012
Last Verified: June 2010

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs