EUS Guided Celiac Neurolysis
Not Applicable
Completed
- Conditions
- Pancreatic Cancer Pain
- Interventions
- Procedure: EUS
- Registration Number
- NCT01615653
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
-
- Unresectable pancreatic carcinoma (T4 or M1) or advanced T3 disease
-
- Cytologic or histologic confirmation of pancreatic carcinoma
-
- Abdominal pain (≥ 3 on NRS scale), ≥ 2 days/week, lasting ≥ 1 hour/ day, stable intensity for ≥ 7 days
-
- EUS clinically indicated (for non-study purposes)
Read More
Exclusion Criteria
-
- Uncorrectable coagulopathy: (INR) > 1.5 and/or platelets < 50,000
-
- Abdominal surgery within 1 month
-
- Prior celiac plexus or ganglia neurolysis.
-
- Initiation or modification in chemotherapy or radiotherapy within prior 7 days.
-
- Direct tumor infiltration of the celiac trunk and/or celiac ganglia.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EUS 2 EUS - EUS 1 EUS -
- Primary Outcome Measures
Name Time Method Pain assessed using a numerical rating scale (NRS) from 0 to 10. Baseline to 6 months pain response will be measured
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States