Phase III Randomized Placebo Controlled Trial of EUS Guided Celiac Plexus Neurolysis for Pancreatic Cancer Pain

Inclusion Criteria:

3.1 Unresectable (T4 or M1 or non-regional lymph nodes) or inoperable (due to medical
comorbidity) carcinoma of the pancreas as determined by CT or EUS. Patients with extensive
portal vein or superior mesenteric vein involvement (T3 by 6th Ed. AJCC staging manual)
will be included only if the consulting surgeon feels the patients is unresectable based
on the CT scan information.

3.2 Presence of mid-abdominal pain ( 3 on VAS scale) at least 2 days per week, lasting at
least 1 hour per day.

3.3 No known coagulopathy as measured by Prothrombin time (INR) 1.5. Pre-EUS INR is not
required unless clinically indicated due to known warfarin use or suspected coagulopathy.

3.4 Patient must not require more than 2 l/min oxygen supplementation to maintain
saturation >90%.

3.5 > 6 months since previous myocardial infarction or angina. 3.6 ≥ 4 weeks since
previous surgery. 3.7 No institution or change in chemotherapy or radiotherapy within 7
days prior (or 14 days post) ESU-CPN. See section 7.0 and 7.1 for details of chemotherapy
and radiotherapy allowances.

3.8 Platelets ≥ 50,000. Pre-EUS CBC is not required unless clinically indicated due to
known or suspected coagulopathy.

3.9 Life expectancy > 3 months 3.10 Signed and dated informed consent.

Exclusion Criteria:

Unable to sign informed consent