EUS Guided Celiac Neurolysis

Mayo Clinic110 enrolled

Overview

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

110

Conditions

Pancreatic Cancer Pain

Interventions

EUSPROCEDURE

EUS Guided Therapy

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Pain assessed using a numerical rating scale (NRS) from 0 to 10.

pain response will be measured

Time frame: Baseline to 6 months

Data from ClinicalTrials.gov

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