EUS-CPN With and Without Bupivacaine

Recruiting · NCT04951804 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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Pancreatic Cancer

Interventions studied

EUS-CPN with bupivacaineEUS-CPN without bupivacaine

What this trial 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 take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

\. Allergy to bupivacaine

Where it is running

1 location listed.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →