Celiac plexus neurolysis with and without bupivacaine for pancreatic cancer pain relief
A Randomized Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Neurolysis (EUS-CPN) With and Without Bupivacaine
This study is testing whether adding a local anesthetic called bupivacaine to a pain relief procedure for pancreatic cancer can improve pain control for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04951804 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of celiac plexus neurolysis (EUS-CPN) in patients with pancreatic cancer, comparing outcomes between those receiving the procedure with and without the local anesthetic bupivacaine. The study aims to determine if the inclusion of bupivacaine affects pain control during and after the procedure, as well as its potential risks. Participants will undergo EUS-guided injections of absolute alcohol around the celiac plexus to alleviate pain associated with their condition. The trial will help clarify the role of bupivacaine in this context, which has not been previously established.
Who should consider this trial
Good fit: Ideal candidates include individuals with a malignant pancreatic mass or proven pancreatic cancer who experience abdominal or back pain related to the disease and are not candidates for surgical management.
Not a fit: Patients with an allergy to bupivacaine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients suffering from pancreatic cancer.
How similar studies have performed: While the approach of celiac plexus neurolysis is established, the specific investigation of bupivacaine's role in this procedure is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail 2. Any level of abdominal or back pain considered to be potentially related to the mass: 1. New onset pain (\<3 months) 2. Constant 3. Centrally located 4. With or without irradiation to the back 5. No obvious other source of pain based on history and physical examination by the attending endosonographer 3. No possibility of surgical management 4. Signed, informed consent 5. Celiac axis accessible for bilateral neurolysis at EUS. Exclusion Criteria: 1\. Allergy to bupivacaine
Where this trial is running
Montreal, Quebec
- Centre de recherche du Centre hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Anand V Sahai, Md — Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study coordinator: Charles Mackay, Rn
- Email: charles.mackay.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.