Endoscopic Ultrasound-guided Celiac Plexus Neurolysis In The Management Of Pain In Abdominal Non-pancreatic Malignancies

Study Overview

Endoscopic Ultrasound-guided Celiac Plexus Neurolysis 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.

N/A

Pain
Cancer

PROCEDURE: EUS-guided Celiac Plexus Neurolysis

NU protocol #0917 (eIRB 20311)

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 2010-07-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-09-23
First Submitted that Met QC Criteria 2010-07-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-09-25
First Posted (ESTIMATED) 2010-07-21	Results First Posted N/A	Last Verified 2014-09

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:
Supportive Care

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: EUS-CPN	PROCEDURE: EUS-guided Celiac Plexus Neurolysis 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 celia

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: EUS-CPN

PROCEDURE: EUS-guided Celiac Plexus Neurolysis

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 celia

Primary Outcome Measures	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)	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	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).	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.		2 months
Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed	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

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:
18 Years

Accepts Healthy Volunteers:

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

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

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

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

General Publications

Christo PJ, Mazloomdoost D. Interventional pain treatments for cancer pain. Ann N Y Acad Sci. 2008 Sep;1138:299-328. doi: 10.1196/annals.1414.034.
Chak A. What is the evidence for EUS-guided celiac plexus block/neurolysis? Gastrointest Endosc. 2009 Feb;69(2 Suppl):S172-3. doi: 10.1016/j.gie.2008.12.022. No abstract available.
Penman ID, Rosch T; EUS 2008 Working Group. EUS 2008 Working Group document: evaluation of EUS-guided celiac plexus neurolysis/block (with video). Gastrointest Endosc. 2009 Feb;69(2 Suppl):S28-31. doi: 10.1016/j.gie.2008.11.004. No abstract available.
Puli SR, Reddy JB, Bechtold ML, Antillon MR, Brugge WR. EUS-guided celiac plexus neurolysis for pain due to chronic pancreatitis or pancreatic cancer pain: a meta-analysis and systematic review. Dig Dis Sci. 2009 Nov;54(11):2330-7. doi: 10.1007/s10620-008-0651-x. Epub 2009 Jan 10.
Daut RL, Cleeland CS, Flanery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain. 1983 Oct;17(2):197-210. doi: 10.1016/0304-3959(83)90143-4.
Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record