EUS-CPN With and Without Bupivacaine

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail
• Any level of abdominal or back pain considered to be potentially related to the mass:
  • New onset pain (<3 months)
  • Constant
  • Centrally located
  • With or without irradiation to the back
  • No obvious other source of pain based on history and physical examination by the attending endosonographer
• No possibility of surgical management
• Signed, informed consent
• Celiac axis accessible for bilateral neurolysis at EUS.

🚫 You may not be able to join if…

• Allergy to bupivacaine

Where this trial is running

• Centre de recherche du Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada

Who to contact

CHARLES MACKAY, RN · 514-890-8000 · charles.mackay.chum@ssss.gouv.qc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT04951804.