EUS Guided Celiac Neurolysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-06-30

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Pancreatic Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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EUS 1

Group Type ACTIVE_COMPARATOR

EUS

Intervention Type PROCEDURE

EUS Guided Therapy

EUS 2

Group Type ACTIVE_COMPARATOR

EUS

Intervention Type PROCEDURE

EUS Guided Therapy

Interventions

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EUS

EUS Guided Therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No