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

August 18, 2014 updated by: Jong Kyun Lee, Samsung Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

166

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. At least 19 years old age (above 70 years old age, need the consent of the legal representative)
  2. Inoperable pancreatic cancer patients
  3. Pancreatic cancer patients with inadequate pain control by pain killer (VAS score 4 points or more)
  4. Patient who agree to participate in this study

Exclusion Criteria:

  1. Abnormal clotting (international normalized ratio ≥1.5)
  2. Reduced platelet count (≤50000/μL)
  3. Use of anticoagulation agents
  4. Presence of gastric and/or esophageal varices
  5. Anatomical deformity due to past surgery

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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 Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

July 21, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-02-088-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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