Pancreatic Cancer Pain
Conditions
Keywords
Pancreatic cancer, Pancreas cancer, Pain, Celiac Plexus, Neurolysis
Brief summary
* 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.
Interventions
PROCEDUREEUS
EUS Guided Therapy
Sponsors
American College of Gastroenterology
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessed using a numerical rating scale (NRS) from 0 to 10. | Baseline to 6 months | pain response will be measured |
Countries
United States
Outcome results
None listed