Inoperable, Painful Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Therapy, Neurolysis
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.
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.
Interventions
PROCEDUREEUS-guided celiac plexus neurolysis
Injection of 20cc of absolute alcohol + 10c of 0.5% bupivicaine on either side of the celiac axis.
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 2. Quality of life 3. Survival | 1 month, 3 months and until death |
Countries
Canada
Contacts
STUDY_DIRECTORAnand Sahai, MD
CHUM, Universite de Montreal
Outcome results
None listed