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2021-10-07
2027-02
2027-12
180
NCT04951804
Centre hospitalier de l'Université de Montréal (CHUM)
Centre hospitalier de l'Université de Montréal (CHUM)
INTERVENTIONAL
EUS-CPN With and Without Bupivacaine
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.
Pancreatic malignancies are the second most frequent 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 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 have 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 peri-pancreatic invasion of neural structures, such as the celiac plexus. Standard analgesics such as acetaminophen are usually ineffective and the use and effectiveness of opioids is frequently limited by side effects such as nausea, constipation, somnolence, confusion or respiratory depression. The celiac plexus is immediately adjacent to the gastric wall. Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of neurolytic agents around the celiac plexus (celiac plexus neurolysis [CPN]). Under conscious sedation, the 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. The entire procedure takes approximately 5 minutes. Absolute alcohol causes the immediate destruction of the celiac plexus neurons, by precipitation of endoneural lipoproteins and mucoproteins. The effectiveness of CPN, is well established. It is safe, produces significant pain reduction, significantly reduces narcotic requirements, and may even increase survival. The investigators were the first to publish a randomized, sham-controlled trial demonstrating the efficacy of EUS-CPN for pain due to pancreatic cancer, and authored the most recent published guidelines on the use of EUS-CPN. Based on our experience in over 1000 neurolysis procedures, patients undergoing EUS-guided CPN may experience pain, acutely during alcohol injection, and sometimes post-procedure, for up to a few hours. (Unpublished observations) It is possible that the presence of pain during injection of alcohol indicates that the celiac plexus has been accurately targeted and may therefore portend better long-term pain control. Currently, during the neurolysis procedure, it is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain during and after the procedure. The true value of bupivacaine during neurolysis has never been studied. 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. In other words, in the worst case scenario, the injection of bupivacaine may increase procedural risk, without any associated benefit in terms of pain reduction. The EUS team at the CHUM stopped using bupivacaine during neurolysis approximately 2 years ago and has noticed no obvious difference in pain during the procedure or in the immediate post-procedure recovery period, no increase in complications, and a possible reduction in requests for repeat neurolysis - suggesting that neurolysis without bupivacaine may be more effective. (Unpublished observations) The investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-06-09 | N/A | 2024-06-18 |
2021-06-28 | N/A | 2024-06-20 |
2021-07-07 | N/A | 2024-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Double
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: EUS-CPN with bupivacaine Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL preceded by injection of 10 ml of bupivacaine 0.5%. | PROCEDURE: EUS-CPN with bupivacaine
|
| EXPERIMENTAL: EUS-CPN without bupivacaine Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL only. | PROCEDURE: EUS-CPN without bupivacaine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in Likert pain scores | Pain scale used : 7-point Likert scale for pain (minimum value is 0, maximum value is 6; higher scores mean a worse outcome) | Day 0 and Day 30 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Difference in pain scores at T0 vs all other follow-up time points | The 7-point Likert scale for pain (minimum value is 0, maximum value is 6; higher scores mean a worse outcome) | Days 0, 3, 7, 30, 60, 90, 120 |
| Time to discharge from the endoscopy unit | Time spent in the recovery room following the procedure | From time of arrival in the recovery room after the intervention to time of discharge from the recovery room. The estimated period of time over which the event is assessed is up to two hours |
| Narcotic usage | Change in cumulative narcotic usage between Day 0 and Day 60, and between Day 0 and Day 120 | Narcotic usage for the 3 day-period preceding Days 0, 60 and 120 |
| Adverse events | Rate of all intervention-specific adverse events (Using the American Society of Gastrointestinal Endoscopy classification) | Days 0, 3, 7, 30, 60, 90, 120 |
| Survival | Number of days between the EUS-CPN intervention and death | Up to 18 months |
| Difference in Global Rating Scale of Change at T3 vs all other follow-up time points | The Global Rating Scale of Change will be used to measure subjects' impression of improvement in their health condition after T0 (the day celiac plexus neurolysis is performed) (minimum value is 0, maximum value is 6; higher scores mean a better outcome) | Days 3, 7, 30, 60, 90, 120 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: CHARLES MACKAY, RN Phone Number: 514-890-8000 Email: charles.mackay.chum@ssss.gouv.qc.ca |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
