A Randomized, Double Blind, Sham-Controlled Trial of EUS-Guided Celiac Plexus Neurolysis (EUS-CPN) for Pain Due to Newly Diagnosed, Inoperable Pancreatic Cancer
18 Years
N/A
Both
Inoperable, Painful Pancreatic Cancer
Trial Information
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.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
1 month, 3 months
Safety Issue:
No
Principal Investigator
Anand Sahai, MD
Investigator Role:
Study Director
Investigator Affiliation:
CHUM, Universite de Montreal
Authority:
Canada: Ethics Review Committee
Study ID:
ND05.083
NCT ID:
NCT00974948
Start Date:
April 2006
Completion Date:
December 2008
Related Keywords:
- Inoperable, Painful Pancreatic Cancer
- Pancreatic cancer
- Therapy
- Neurolysis
- Pancreatic Neoplasms
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