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2006-04
2008-12
2008-12
100
NCT00974948
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
INTERVENTIONAL
Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
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 longer responds to treatment with narcotics. The investigators compare standard narcotic treatment to celiac plexus alcohol injection (celiac plexus neurolysis) and do so in patients with early, mild pain to see if celiac plexus neurolysis is more effective than narcotics and prevents escalating narcotic use.
This is a randomized, double blind, sham-controlled trial designed to evaluate the efficacy of early EUS-guided celiac plexus neurolysis (EUS-CPN). ⋪rly" 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2009-09-10 | N/A | 2009-09-10 |
2009-09-10 | N/A | 2009-09-11 |
2009-09-11 | N/A | 2009-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Neurolysis Patients will undergo EUS followed by EUS-guided, bilateral neurolysis with bupivicaine and absolute alcohol. | PROCEDURE: EUS-guided celiac plexus neurolysis
|
| NO_INTERVENTION: Conventional therapy EUS will be performed with no celiac plexus neurolysis. |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 2. Quality of life 3. Survival | 1 month, 3 months and until death |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
