Status:
WITHDRAWN
Endoscopic Ultrasound-guided Celiac Plexus Neurolysis in the Management of Pain in Abdominal Non-pancreatic Malignancies
Lead Sponsor:
Northwestern University
Conditions:
Pain
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01166529
Start Date
August 1 2010
End Date
July 1 2013
Last Update
September 25 2014
Active Locations (1)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611