Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments endoscopic ultrasound-guided celiax plexus neurolysis, bupivacaine
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Start date March 2016
End date March 2017
Trial size 84 participants
Trial identifier NCT02682082, CE 15.246

Summary

The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea, excessive sedation, constipation).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Experimental Group: Endoscopic ultrasound guided celiac plexus Neurolysis without Bupivacaine so only with Absolute Alcohol 20 mL
endoscopic ultrasound-guided celiax plexus neurolysis
Endoscopic ultrasound-guided celiax plexus neurolysis
(Active Comparator)
Endoscopic ultrasound guided celiac plexus Neurolysis with Bupivacaine (0.5% Bupivicaine 20mL + Absolute Alcohol 20 mL)
endoscopic ultrasound-guided celiax plexus neurolysis
Endoscopic ultrasound-guided celiax plexus neurolysis
bupivacaine
Endoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine

Primary Outcomes

Measure
Difference in pain scores at 1 month and end of the trial
time frame: 1 month and 120 days post procedure

Secondary Outcomes

Measure
Difference in quality of life scores at 1 month and end of the trial
time frame: 1 month and 120 days post procedure
Difference in cumulative narcotic usage at 1 month and end of the trial
time frame: 1 month and 120 days post procedure
Difference in survival
time frame: 1 month and 120 days post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Confirmed malignant pancreatic lesion involving the pancreatic genu, body, or tail - Abdominal or back pain considered to be potentially related to the tumor - 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 Exclusion Criteria: - Allergy to bupivicaine - Age < 18 years - Inability or unwillingness to give informed consent

Additional Information

Official title A Randomize Double-Blind Control Trial Study Comparing Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis W/Wo Bupivacaine In Patient Being Treated Palliatively For Pancreatic Cancer
Principal investigator Anand Sahai, M.D
Description Pancreatic malignancies are the second highest incident gastrointestinal malignancy in Canada. From cancer mortality statistics in 2014, there were 4,700 new cases of pancreatic malignancies second only to colorectal cancer, representing 2.4% of all cancers . Even with chemotherapy, the median survival for patients with pancreatic adenocarcinoma is 6 to 10 months. Few of the patients are diagnosed at a resectable stage (12%-20%) so many patients are candidates for palliation only.In this context, one of the most important symptoms is pain because it often affects both quality of life and survival.70 to 80 % of patients with Pancreatic cancer had abdominal pain at the time of diagnosis . Adequate pain control is therefore an essential component of care in these patients. In the initial phase, the pain is visceral, but with disease progression, somatic pain may occur, especially due to the peripancreatic invasion of neural structures or muscles. Standard analgesics such as Acetaminophen are ineffective and administration of opioids is frequently limited by side effects such as nausea, constipation, somnolence, addiction, confusion or respiratory depression, and failure in achieving adequate analgesia. In these situations, neurodestructive methods of celiac plexus with Absolute Alcohol associated to Bupivacaine involving the main pancreatic pain pathways, seem efficient. Alcohol causes the immediate precipitation of endoneural lipoproteins and mucoproteins within the celiac plexus, leading to the extraction of cholesterol and phospholipids from the neural membrane. To prevent severe transient pain after the procedure, Bupivacaine was injected before the Alcohol injection. Interest and importance of EUS-CPN is well established (safe, more effective than percutaneous or CT guided celiac plexus Neurolysis, significant reduction in pain and significant reduction of narcotics requirements) however the role and effect of Bupivacaine on the effectiveness of Neurolysis and lytic power of Alcohol has never been studied . Is it a synergistic effect ? Or an antagonistic effect by diluting Alcohol ? The Centre hospitalier de l'université de Montréal (CHUM) is currently the busiest EUS center in the world and has the largest experience with EUS-guided CPN. The CHUM also probably see more pancreatic cancers annually than any other center (more than 300 proven cases/year). There are no published reports of serious adverse events associated with this procedure and this has been the investigators experience as well. Patients may however experience some mild to moderate discomfort during the initial injection of the absolute ethanol solution, but this is usually short lived (less than 30 minutes in our experience). Therefore, Bupivacaine is currently injected before the Ethanol injection, however, local anesthetic was not used before the Phenol injection for example because it has been reported that Phenol has an immediate local anesthetic effect. The investigators believe that, Bupivacaine has no effect and instead it dilutes the alcohol and then reduces the lytic power of Ethanol. This study was designed to test this hypothesis prospectively. The goal of this project is to determine if EUS-CPN without Bupivacaine (versus EUS-CPN with Bupivacaine) can reduce pain scores and improve quality of life in patients with inoperable pancreatic cancer by reducing the morbidity due to narcotic side effects (e.g. nausea, excessive sedation, constipation).
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM).