RECRUITINGINTERVENTIONAL

EUS-CPN With and Without Bupivacaine

A Randomized Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Neurolysis (EUS-CPN) With and Without Bupivacaine

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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, willing to sign a consent form 5. Celiac axis accessible for bilateral neurolysis at EUS. Who Should NOT Join This Trial: 1\. Allergy to bupivacaine Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

EUS-CPN without bupivacaine

Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to inject a neurolytic agent such as absolute alcohol around the base of the celiac artery.

PROCEDURE

EUS-CPN with bupivacaine

Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to firstly inject bupivacaine and secondly a neurolytic agent such as absolute alcohol around the base of the celiac artery.

Locations (1)

Centre de recherche du Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada