| NCT ID | NCT04951804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2021-10-07 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2021-10-07 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer. It is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain that may occur during and after the procedure. However, there are no data showing whether bupivacaine injection has any real influence on intra-procedural, immediate post-procedural, or long-term pain control. The injection of bupivacaine before the alcohol may have no effect, a synergistic effect, or an antagonistic effect, by diluting the alcohol, and reducing its neurolytic capacity. Inadvertent intravascular injection of bupivacaine may also cause irreversible cardiac arrhythmias and death. The investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.
Eligibility 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
Contact & Investigator
ANAND V SAHAI, MD
PRINCIPAL INVESTIGATOR
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Frequently Asked Questions
Who can join the NCT04951804 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04951804 currently recruiting?
Yes, NCT04951804 is actively recruiting participants. Contact the research team at charles.mackay.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT04951804 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04951804 clinical trial?
NCT04951804 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is ANAND V SAHAI, MD at Centre de Recherche du Centre Hospitalier de l'Université de Montréal. The trial plans to enroll 180 participants.
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