EUS-CPN With vs Without Bupivacaine for Pancreatic Cancer

(EUS-NB Trial)

Overseen By CHARLES MACKAY, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Bupivacaine

Disqualifiers: Allergy to bupivacaine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to see if skipping a pain-numbing drug called bupivacaine before injecting alcohol around a nerve cluster can improve pain relief for pancreatic cancer patients. The alcohol destroys nerve cells that send pain signals, helping to manage severe pain. The study will compare outcomes with and without bupivacaine to find the best approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is EUS-CPN with or without bupivacaine safe for humans?

EUS-guided celiac plexus neurolysis (EUS-CPN) is generally considered safe for humans, with serious complications being rare. Common side effects include diarrhea, low blood pressure when standing up, and a temporary increase in abdominal pain. ^{1 2 3 4 5}

How is the treatment EUS-CPN with bupivacaine different from other treatments for pancreatic cancer?

EUS-CPN with bupivacaine is unique because it combines a local anesthetic (bupivacaine) with alcohol to target and destroy nerve tissue around the celiac plexus, providing pain relief for pancreatic cancer patients. This approach is specifically guided by endoscopic ultrasound, allowing precise delivery of the treatment to reduce pain in inoperable cases. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment EUS-CPN with bupivacaine for pancreatic cancer?

Research shows that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) improves pain control in patients with inoperable pancreatic cancer. Studies have also compared the use of bupivacaine, a local anesthetic, in this procedure, indicating its role in minimizing discomfort during the treatment. ^{1 3 5 6 7}

Who Is on the Research Team?

Anand V Sahai, MD

Principal Investigator

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Are You a Good Fit for This Trial?

This trial is for individuals with pancreatic cancer who experience abdominal or back pain potentially related to the tumor. They must have a mass in specific parts of the pancreas, not be candidates for surgery, and able to undergo a procedure called EUS-CPN. People allergic to bupivacaine cannot participate.

Inclusion Criteria

My celiac axis can be accessed for a specific nerve block procedure.

I have new or constant abdominal or back pain, not caused by anything else, and surgery isn't an option for it.

Signed, informed consent

Exclusion Criteria

You are allergic to bupivacaine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EUS-guided celiac plexus neurolysis with or without bupivacaine

1 day

1 visit (in-person)

Immediate Post-procedure Recovery

Participants are monitored in the recovery room following the procedure

Up to 2 hours

Follow-up

Participants are monitored for pain control and adverse events

4 months

Multiple visits (in-person and virtual) on Days 3, 7, 30, 60, 90, 120

What Are the Treatments Tested in This Trial?

Interventions

• EUS-CPN with bupivacaine
• EUS-CPN without bupivacaine

Trial Overview The study is testing whether injecting alcohol without bupivacaine around certain nerves using an endoscopic ultrasound (EUS) technique provides better pain relief for pancreatic cancer patients than when bupivacaine is used before alcohol injection.

How Is the Trial Designed?

Group I: EUS-CPN without bupivacaine Experimental Treatment 1 Intervention

Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL only.

Group II: EUS-CPN with bupivacaine Active Control 1 Intervention

Endoscopic ultrasound guided celiac plexus neurolysis with absolute alcohol 20 mL preceded by injection of 10 ml of bupivacaine 0.5%.

EUS-CPN with bupivacaine is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as EUS-CPN for:

• Pain management in pancreatic cancer

Approved in European Union as EUS-CPN for:

• Pain management in pancreatic cancer
• Pain management in chronic pancreatitis

Approved in Canada as EUS-CPN for:

• Pain management in pancreatic cancer

Approved in Japan as EUS-CPN for:

• Pain management in pancreatic cancer

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study of 150 patients undergoing endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN), the use of 0.75% bupivacaine significantly reduced post-procedural pain compared to 0.375% bupivacaine and 0.5% ropivacaine.

Ropivacaine was associated with a lower incidence of post-procedural arrhythmia compared to bupivacaine, suggesting it may have a safer profile regarding heart-related side effects during EUS-CPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective multicenter study comparing bupivacaine and ropivacaine in endoscopic ultrasound guided celiac plexus neurolysis. Zhao, Y., Guo, X., Wang, K., et al.[2021]

A randomized controlled trial is being conducted to evaluate the necessity of bupivacaine during endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) for pain management in patients with inoperable pancreatic cancer and other malignancies.

The study hypothesizes that bupivacaine may not only be unnecessary but could also pose safety risks, such as serious adverse events, by potentially diluting the effectiveness of the neurolytic alcohol used in the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine. Esmail, E., Paquin, SC., Sahai, AV.[2023]

Early endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) significantly reduces pain in patients with inoperable pancreatic cancer, showing a greater decrease in pain scores at 3 months compared to conventional pain management.

While morphine consumption was similar at 1 month, the EUS-CPN group tended to use less morphine at 3 months, suggesting a potential benefit in reducing opioid use, although there was no observed impact on quality of life or survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. Wyse, JM., Carone, M., Paquin, SC., et al.[2013]

In a study of 67 patients with advanced abdominal cancer, EUS-guided broad plexus neurolysis (EUS-BPN) was found to provide significantly better pain relief compared to standard EUS-guided celiac plexus neurolysis (EUS-CPN), particularly for patients with more extensive neurolytic spread.

EUS-BPN resulted in a higher percentage of patients achieving complete neurolytic coverage (42% vs. 0% in EUS-CPN), leading to greater reductions in pain scores at both 7 and 30 days post-procedure, all while maintaining a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided broad plexus neurolysis over the superior mesenteric artery using a 25-gauge needle. Sakamoto, H., Kitano, M., Kamata, K., et al.[2016]

A systematic review of six studies with 437 patients found that both bilateral and unilateral endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) provide similar short-term pain relief for pancreatic cancer patients.

The bilateral approach to EUS-CPN significantly reduces the need for postoperative analgesics compared to the unilateral approach, suggesting it may be more effective in managing pain after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral vs. unilateral endoscopic ultrasound-guided celiac plexus neurolysis for abdominal pain management in patients with pancreatic malignancy: a systematic review and meta-analysis. Lu, F., Dong, J., Tang, Y., et al.[2019]

Celiac plexus neurolysis (CPN) is an effective method for managing abdominal pain in pancreatic cancer patients, providing pain relief without the side effects associated with opioids.

Endoscopic ultrasound (EUS)-guided techniques, including EUS-CGN and EUS-BPN, enhance the safety and efficacy of neurolysis by allowing precise targeting of the celiac plexus and ganglia, minimizing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided neurolysis in pancreatic cancer. Sakamoto, H., Kitano, M., Komaki, T., et al.[2022]

EUS-guided celiac plexus block (CPB) and neurolysis (CPN) are effective interventions for managing abdominal pain related to pancreatic diseases, providing pain relief in about 70-80% of patients with pancreatic cancer and 50-60% of those with chronic pancreatitis.

Serious complications from these procedures are rare, with the most common side effects being diarrhea, orthostatic hypotension, and temporary increases in abdominal pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound-Guided Celiac Plexus Interventions. Moutinho-Ribeiro, P., Costa-Moreira, P., Caldeira, A., et al.[2021]

Citations

1. China pubmed.ncbi.nlm.nih.gov

A retrospective multicenter study comparing bupivacaine and ropivacaine in endoscopic ultrasound guided celiac plexus neurolysis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, controlled trial of early endoscopic ultrasound-guided celiac plexus neurolysis to prevent pain progression in patients with newly diagnosed, painful, inoperable pancreatic cancer. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

EUS-guided broad plexus neurolysis over the superior mesenteric artery using a 25-gauge needle. [2016]

5. Germany pubmed.ncbi.nlm.nih.gov

Bilateral vs. unilateral endoscopic ultrasound-guided celiac plexus neurolysis for abdominal pain management in patients with pancreatic malignancy: a systematic review and meta-analysis. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided neurolysis in pancreatic cancer. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound-Guided Celiac Plexus Interventions. [2021]