Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: dehydrated alcohol
Intervention description: subject randomized to 10ml or 20ml of dehydrated alcohol one time during the EUS-CPN procedure
Intervention MeSH terms: Ethanol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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)
    

Eligibility 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.