Randomized, Controlled Trial Of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis Vs Celiac Ganglia Neurolysis To Control Pain In Inoperable Pancreatic Cancer Patients With Inadequate Pain Control By Pain Killer

Study Overview

Randomized, Controlled Trial of Endoscopic Ultrasound-Guided Bilateral Celiac Plexus Neurolysis vs Celiac Ganglia Neurolysis to Control Pain in Inoperable Pancreatic Cancer Patients With Inadequate Pain Control by Pain Killer

Pancreatic cancer related pain can be difficult to control, even with high doses of narcotics, whose adverse effects may further impair quality of life. So EUS-CPN(endoscopic ultrasound guided celiac plexus neurolysis) is well established as an effective technique for controlling pain and reducing narcotic requirements in patients with pancreatic cancer. Recently, celiac ganglia can be visualized and accessed by endoscopic ultrasound. So it allows for direct injection into individual celiac ganglia to perform celiac ganglia neurolysis. This more precise delivery of therapeutic drug will offers the potential for enhanced efficacy and safety. To evaluate this hypothesis, this randomized controlled trial aimed to compare the efficacy and safety of EUS-CGN(Endoscopic ultrasound guided celiac ganglia neurolysis) vs. Bilateral EUS-CPN(Endoscopic ultrasound guided celiac plexus neurolysis) in providing relief from pancreas cancer-related pain.

N/A

Pancreatic Neoplasms

PROCEDURE: EUS-CPN
PROCEDURE: EUS-CGN

2014-02-088-005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-07-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-08-18
First Submitted that Met QC Criteria 2014-08-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-08-19
First Posted (ESTIMATED) 2014-08-19	Results First Posted N/A	Last Verified 2014-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: EUS-CPN group Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis	PROCEDURE: EUS-CPN After initially identifying the celiac trunk on endoscopic ultrasound, each injection of 5~10cc ethanol would be performed as bilateral injections at the celiac trunk.
EXPERIMENTAL: EUS-CGN group Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis	PROCEDURE: EUS-CGN First, identify celiac ganglia. If the celiac ganglia are visualized under linear EUS, the injection of 2~3cc ethanol are applied directly into the each ganglia. If the ganglia are not identified by EUS, bilateral EUS-CPN would be performed

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: EUS-CPN group

Group that be performed by Endoscopic ultrasound guided bilateral celiac plexus neurolysis

PROCEDURE: EUS-CPN

After initially identifying the celiac trunk on endoscopic ultrasound, each injection of 5~10cc ethanol would be performed as bilateral injections at the celiac trunk.

EXPERIMENTAL: EUS-CGN group

Group that be performed by Endoscopic ultrasound guided celiac ganglia neurolysis

PROCEDURE: EUS-CGN

First, identify celiac ganglia. If the celiac ganglia are visualized under linear EUS, the injection of 2~3cc ethanol are applied directly into the each ganglia. If the ganglia are not identified by EUS, bilateral EUS-CPN would be performed

Primary Outcome Measures	Measure Description	Time Frame
percentage of participants with 50% decrease or less than 3 points in Pain Visual Analogue Scale (VAS)		1 week after procedure

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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