Evaluation of Injection Techniques in Celiac Plexus Neurolysis
Condition: Pancreatic Cancer; Pain
Study type: Interventional

Summary: 
      1. To evaluate the efficacy of EUS-CPN in subjects who experience a sympathetic response
      during injection when compared with subjects who do not experience sympathetic response
      during injection.

      EUS-CPN when performed in subjects who experience a sympathetic response during injection
      will have better pain relief when compared to subjects who do not experience a sympathetic
      response during injection.
    

Detailed description: 
      1. All adult patients with radiologically consistent pancreatic carcinoma referred to
           Florida Hospital to undergo EUS for staging and diagnostic FNA of pancreatic mass
           lesions will be eligible for study entry.

           A history and physical examination will be performed to determine the character and
           quality of the pain and to evaluate for any contraindication for which EUS cannot be
           performed.

        2. Written informed consent for study participation will be obtained at the same time as
           the consent for the procedure as this study is comparing standard of care treatment
           options in a regular treatment setting. Then, after giving written informed consents and
           prior to the index procedure, all patients will complete the following written
           assessments:

             1. Standardized 11-point continuous visual analog pain scale (12)

             2. Quality of life instruments: Functional Assessment of Cancer Therapy, Pancreatic
                Cancer (FACT-PA) (i.e. QLQ-30 and PAN-26) (13)

             3. Pain medication usage over prior 2 days (converted to equianalgesic doses of
                morphine)

        3. EUS will be performed in standard fashion by one of three experienced endoscopists

        4. Eligible patients will be included if pancreatic carcinoma is confirmed by FNA performed
           during EUS and if EUS or CT staging shows unresectability of the tumor. Cytology
           evaluation of FNA is routinely provided during procedure by pathologist into the
           endoscopy room at our institution.

           During EUS, included patients will receive CPN in the standard fashion. Whether a
           sympathetic response occurs or not during CPN, this will be documented. Sympathetic
           response will be defined as change in heart rate by >10 bpm and change in BP <10mmHg.
           The technique of EUS-CPN is as follows:

             -  Using a curvilinear array echoendosocpe, the region of the celiac plexus is
                visualized from the lesser curvature of the stomach by following the aorta to the
                origin of the main celiac artery. It is traced, by using counter-clockwise
                rotation, to its bifurcation into splenic and hepatic arteries, with Doppler US
                control if needed.

             -  CPN will be undertaken at the celiac space which is located between the aorta and
                the celiac artery origin.

             -  A 20-gauge fenestrated CPN needle is used, its tip is placed slightly anterior and
                cephalic to the origin of the celiac artery.

             -  Aspiration is first performed to ensure that vascular puncture has not occurred.

             -  Bupivacaine is injected first, followed by alcohol.

             -  Patients will be observed for 2 to 4 hours, with careful monitoring of pulse, blood
                pressure and temperature.

        5. Following EUS, patients will be discharged and called at home by research nurse at 24
           hours for evidence of pancreatitis or other complications from the procedure, Clinical
           research nurse* will also contact the patient at 1, 2, 4 weeks after EUS and then
           monthly until death or 1 year. Clinical research nurse* will be blinded to the
           documentation about sympathetic response. Assessment of pain scale, QOL, medication use
           and side effects will be performed.

        6. Following CPN, EUS operator will not be actively involved in patient care.

        7. Medical decisions for each patient will be made by the patient's primary physician and
           oncologist.

        8. Patient can be referred for rescue CPN if the patient's primary physician and oncologist
           feel that this is warranted.
    

Intervention name(s): Sympathetic response; no sympathetic response
Intervention type(s): Other; Other
Intervention description(s): Sympathetic response will be defined as change in heart rate by >10 bpm and change in BP <10mmHg.; no Sympathetic response will be defined as change in heart rate by <10 bpm and change in BP <10mmHg.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)