Trial of Endoscopic Ultrasound (EUS) - Guided Celiac Plexus Neurolysis
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 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.
Study Design
Arms and Interventions
| 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
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. |
Outcome Measures
Primary Outcome Measures
- 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
- 2. Quality of life 3. Survival [1 month, 3 months and until death]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHUM | Montreal | Quebec | Canada | H2X 3J4 |
Sponsors and Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
- Study Director: Anand Sahai, MD, CHUM, Universite de Montreal
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ND05.083