Text Size

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

This study is currently recruiting participants.
Verified July 2011 by Northwestern University
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT01166529
First received: July 19, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Pain
Cancer
 Procedure: EUS-guided Celiac Plexus Neurolysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Endoscopic Ultrasound (EUS)-Guided Celiac Plexus Neurolysis (CPN) in the Management of Pain in Abdominal Non-pancreatic Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
  • Narcotic use over a 24-hour period will be documented each time the Brief Pain Inventory (BPI) is completed [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166529

Contacts
Contact: Raj N Keswani, MD (312)-695-8174 rkeswani@nmff.org
Contact: David M Shapiro, MD (312)-695-4065 d-shapiro3@md.northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Raj N Keswani, MD     312-695-8174     rkeswani@nmff.org    
Principal Investigator: Raj N Keswani, MD            
Sub-Investigator: Mary F Mulcahy, MD            
Sub-Investigator: David M Shapiro, MD            
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Raj N Keswani, MD Northwestern University
  More Information

Publications:

Responsible Party: Raj Keswani, M.D./Assistant Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01166529     History of Changes
Other Study ID Numbers: NU protocol #0917 (eIRB 20311)
Study First Received: July 19, 2010
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013