A Randomized, Double Blind, Sham-Controlled Trial of EUS-Guided Celiac Plexus Neurolysis (EUS-CPN) for Pain Due to Newly Diagnosed, Inoperable Pancreatic Cancer
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 previous CPN trials, we targeted patients with inoperable, painful pancreatic
cancer in whom pain was mild and who were taking little or no narcotics. Our a priori
hypotheses were that, compared to conventional management with narcotics alone, early
neurolysis: 1) will better control pain related to inoperable pancreatic cancer, 2) will
prevent the escalating use of narcotics associated with disease progression, 3) will improve
quality of life, and 4) will improve survival. The aim our study is to test these 4
hypotheses.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Absolute and relative changes in 7-point Likert-score for abdominal pain at 1 and 3 months post-randomization. Secondary endpoints were change in morphine equivalent consumption (MEQ), quality of life (DDQ-15), and overall survival.
1 month, 3 months
No
Anand Sahai, MD
Study Director
CHUM, Universite de Montreal
Canada: Ethics Review Committee
ND05.083
NCT00974948
April 2006
December 2008
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