MedPath

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EUS 2EUS-
EUS 1EUS-
Primary Outcome Measures
NameTimeMethod
Pain assessed using a numerical rating scale (NRS) from 0 to 10.Baseline to 6 months

pain response will be measured

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mayo Clinic

🇺🇸

Rochester, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath