Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
Phase 4
N/A
N/A
N/A
N/A
Open (Enrolling)
Both
Pancreatic Cancer Pain
Both
Pancreatic Cancer Pain
Trial Information
Prospective Randomized Trial of EUS Guided Celiac Ganglia Neurolysis (CGN) Versus EUS Guided Celiac Plexus Neurolysis (CPN) for Pancreatic Cancer Pain
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Pain assessed using a numerical rating scale (NRS) from 0 to 10.
Outcome Description:
pain response will be measured
Outcome Time Frame:
Baseline to 6 months
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
09-005037
NCT ID:
NCT01615653
Start Date:
September 2009
Completion Date:
September 2014
Related Keywords:
- Pancreatic Cancer Pain
- Pancreatic cancer
- Pancreas cancer
- Pain
- Celiac Plexus
- Neurolysis
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
