Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
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|ClinicalTrials.gov Identifier: NCT00974948|
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : September 11, 2009
|Condition or disease||Intervention/treatment||Phase|
|Inoperable, Painful Pancreatic Cancer||Procedure: EUS-guided celiac plexus neurolysis||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Randomized, Double Blind, Sham-Controlled Trial of EUS-Guided Celiac Plexus Neurolysis (EUS-CPN) for Pain Due to Newly Diagnosed, Inoperable Pancreatic Cancer|
|Study Start Date :||April 2006|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
Active Comparator: Neurolysis
Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol.
Procedure: EUS-guided celiac plexus neurolysis
Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.
No Intervention: Conventional therapy
EUS will be performed with no celiac plexus neurolysis.
- 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. [ Time Frame: 1 month, 3 months ]
- 2. Quality of life 3. Survival [ Time Frame: 1 month, 3 months and until death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974948
|Montreal, Quebec, Canada, H2X 3J4|
|Study Director:||Anand Sahai, MD||CHUM, Universite de Montreal|