Endoscopic Ultrasound-guided Celiac Plexus Neurolysis in the Management of Pain in Abdominal Non-pancreatic Malignancies

September 23, 2014 updated by: Rajesh Keswani, Northwestern University

Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies

Celiac plexus neurolysis (CPN) has been performed for nearly 100 years to alleviate the abdominal pain associated with pancreatic malignancy and other conditions, and is usually undertaken at a late stage in the disease process, when analgesic options have been largely exhausted or have led to significant and often unacceptable side effects. Until recently, CPN was most commonly performed under radiographic guidance; however, in the last 10 years, CPN has been routinely performed under endoscopic ultrasound (EUS) guidance. Several case series have demonstrated the efficacy and safety of this technique when used to treat the pain associated with pancreatic malignancy and/or chronic pancreatitis. However, the efficacy of EUS-guided CPN in the treatment of pain related to non-pancreatic malignancies has yet to be described. The goal of this study is to assess the efficacy of EUS-guided CPN in the management of pain in patients with abdominal non-pancreatic malignancies. Our hypothesis is that EUS-guided CPN will provide adequate pain relief in these patients.

Study Overview

Status

Withdrawn

Conditions

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of an unresectable, non-pancreatic malignancy, including gastric, small intestinal, or proximal colonic malignancies, as well as malignancies of the liver and bile ducts (based on above celiac plexus innervations)
  • Pain directly related to the primary malignant process, as determined by the referring oncologist
  • Pain determined to be refractory to standard medical therapy, or when the medical therapy is ineffective due to certain limitations (such as severe constipation), as determined by the referring oncologist
  • Willingness to undergo EUS-guided CPN
  • Age > 18 years
  • ECOG performance status of grades 0-3 [7]
  • The patient will need to sign informed consent prior to inclusion in this study

Exclusion Criteria:

  • Unable or unwilling to undergo an EUS-guided CPN
  • Contraindication to anesthesia, as determine during the preoperative clearance process
  • Refractory coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000), or aspirin and/or clopidogrel use within 7 days of procedure
  • Current pregnancy
  • Prior celiac plexus block/neurolysis
  • Allergy to local anesthetics
  • ECOG performance status of grade 4 or higher

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: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EUS-CPN
All patients will receive anesthesia. The linear echo-endoscope will be advanced into the proximal stomach. It will be noted whether the tumor is seen in the celiac axis, if there is flow in the celiac artery, and if the celiac ganglia are seen. The celiac ganglia will be injected directly with 10cc of 0.25% bupivicaine followed by 10cc of 98% dehydrated alcohol. If the celiac ganglia cannot be identified, the posterior and anterior aspects of celiac artery take-off will be injected in a similar manner (twice the volume). Flow in the celiac axis will be confirmed. All injections will be performed with a standard EUS injection needle made especially for CPN . Prior to injection, aspiration will be performed through the needle to ensure that no blood is aspirated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between the mean pain score prior to and 1 month after the procedure, as determined by the Brief Pain Inventory (BPI)
Time Frame: 1 month
The BPI will be filled out just prior to and 1 month after the procedure to assess the difference in the mean pain score after the procedure
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in mean pain scores before and at 1 day after the procedure, 7 days after the procedure, 14 days after the procedure, and at 2 months after the procedure, as determined by the Brief Pain Inventory (BPI).
Time Frame: 2 months
The BPI will be filled out just prior to the procedure and after the procedure at the above intervals (up to 2 months) to assess the difference in the mean pain scores after the procedure.
2 months
Difference in the mean 'level of interference of pain with daily life' score, as determined by the Brief Pain Inventory (BPI). This score will be determined before and after the procedure, determined at the same intervals as mean pain scores.
Time Frame: 2 months
2 months
Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed
Time Frame: 2 months
Names, doses, and quantity of pain medications will be reported and converted to an equianalgesic dose (mg/day) of orally administered morphine. The difference in equianalgesic doses (mg/day) will be determined at the same intervals as mean pain scores.
2 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Raj N Keswani, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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, 2010

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (ESTIMATE)

July 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU protocol #0917 (eIRB 20311)

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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