Status:
COMPLETED
Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Inoperable, Painful Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Pancreatic cancer presents with pain in the majority of cases. Destruction of the celiac ganglia by ultrasound guided injection of sclerosing agents such as alcohol is sometimes used for pain that no ...
Detailed Description
This is a randomized, double blind, sham-controlled trial designed to evaluate the efficacy of early EUS-guided celiac plexus neurolysis (EUS-CPN). "Early" refers to the fact that, in contrast to prev...
Eligibility Criteria
Inclusion
- previous imaging and/or the EUS examination demonstrated inoperable pancreatic cancer defined as involvement of the superior mesenteric vein, portal vein or confluence, superior mesenteric artery, celiac axis, hepatic artery, or non-regional lymphadenopathy
- a new diagnosis of pancreatic adenocarcinoma was confirmed by an on-site cytopathologist following EUS fine needle aspiration (EUS-FNA)
Exclusion
- allergy to bupivicaine
- possible future surgical management of the tumor
- expected survival less than 3months (suspected or proven carcinomatosis or liver metastases)
- inability or unwillingness to provide informed consent prior to the EUS
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00974948
Start Date
April 1 2006
End Date
December 1 2008
Last Update
September 11 2009
Active Locations (1)
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1
CHUM
Montreal, Quebec, Canada, H2X 3J4