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Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN) With Alcohol in Patients With Locally Advanced and Unresectable Pancreatic Adenocarcinoma: A Randomized Pilot Study

Phase 4
18 Years
Not Enrolling
Pancreatic Cancer

Thank you

Trial Information

Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN) With Alcohol in Patients With Locally Advanced and Unresectable Pancreatic Adenocarcinoma: A Randomized Pilot Study

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The Change in Mean Pain Scale Rating in Patients Following Treatment With 10mL or 20mL of Alcohol Injection

Outcome Description:

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.

Outcome Time Frame:

baseline up to 1 year

Safety Issue:


Principal Investigator

Julia LeBlanc, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

June 2009

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



Clarian Health: Indiana University HospitalIndianapolis, Indiana  46202