Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain

Location:

Rochester, Minn.

Trial status:
Open for Enrollment
Why is this study being done?

- Hypothesis: - Direct CGN enhances neurolytic drug delivery into celiac ganglia and increases the efficacy of neurolysis and subsequent pain control and survival in patients with pancreatic carcinoma. - Rationale: - Standard CPN leads to inaccurate delivery of the injectate with rapid dispersal thereby only briefly remaining in contact with neural structures and limiting the degree of neurolysis. Poor targeting and delivery of a neurolytic agent may result in diminished neurolysis and decrease efficacy.

Who is eligible to participate?

Inclusion Criteria: - 1. Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease - 2. Cytologic or histologic confirmation of pancreatic carcinoma - 3. Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days - 4. EUS clinically indicated (for non-study purposes) Exclusion Criteria: - 1. Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000 - 2. Abdominal surgery within 1 month - 3. Prior celiac plexus or ganglia neurolysis. - 4. Initiation or modification in chemotherapy or radiotherapy within prior 7 days. - 5. Direct tumor infiltration of the celiac trunk and/or celiac ganglia.

Last updated:
10/7/2013
NCT ID:
NCT01615653
IRB Number:
09-005037