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 explores whether using a numbing medicine called bupivacaine during a procedure helps manage pain for people with pancreatic cancer. The procedure, Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis (EUS-CPN), involves injecting alcohol around a nerve area to relieve pain. Researchers aim to determine if omitting bupivacaine might lead to better pain control during and after the procedure. Suitable participants have a pancreatic mass causing constant abdominal or back pain and cannot undergo surgery. The trial seeks to improve pain relief techniques for those dealing with pancreatic cancer. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management strategies for pancreatic cancer patients.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) can help manage pain in people with pancreatic cancer. Past studies have found EUS-CPN reduces pain in up to 70% of patients. This procedure uses pure alcohol to numb the nerves, relieving pain.

When combined with bupivacaine, a local anesthetic, EUS-CPN is believed to prevent pain during the procedure. However, clear evidence does not support that bupivacaine significantly improves pain relief. Concerns exist that if bupivacaine accidentally enters a blood vessel, it could cause serious heart problems.

Researchers are also studying EUS-CPN without bupivacaine to determine if omitting the anesthetic might lead to better results. Both methods aim to control pain, but more research is needed to directly compare their safety and effectiveness.

In summary, while EUS-CPN is generally well-tolerated, the impact of bupivacaine on improving or complicating the procedure remains under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for pancreatic cancer pain, which often involves systemic pain relievers like opioids, EUS-CPN with bupivacaine offers a targeted approach. It combines an endoscopic ultrasound-guided technique with a nerve-numbing agent, bupivacaine, to potentially enhance pain relief directly at the source. Researchers are excited because this method could reduce the need for opioids, minimizing their side effects, and provide quicker, more localized pain management. The addition of bupivacaine may improve the efficacy and duration of relief compared to using alcohol alone in the nerve-blocking procedure.

What evidence suggests that this trial's treatments could be effective for pancreatic cancer pain?

Research shows that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) can reduce pain in people with pancreatic cancer. Studies have found that about 70% of patients experience pain relief from EUS-CPN. This procedure involves injecting pure alcohol near certain nerves to block pain signals. In this trial, participants will receive either EUS-CPN with bupivacaine or without it. Uncertainty exists about whether adding bupivacaine, a numbing medicine, before the alcohol affects the outcome. Some believe bupivacaine might help or hinder the process, but clear evidence is lacking. EUS-CPN, with or without bupivacaine, remains an option for managing pain in this condition. ^{1 2 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

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10486028/

Protocol for a randomized controlled trial of endoscopic ... Randomized controlled trial have shown that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) improves pain control. It is usually ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04951804

NCT04951804 | EUS-CPN With and Without Bupivacaine The investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37684697/

Protocol for a randomized controlled trial of endoscopic ... Randomized controlled trial have shown that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) improves pain control. It is usually ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2010.32.2750

Randomized, Double-Blind, Controlled Trial of Early ... Early EUS-CPN reduces pain and may moderate morphine consumption in patients with painful, inoperable pancreatic adenocarcinoma.

5. tandfonline.com tandfonline.com/doi/full/10.1080/20009666.2021.1929049

Full article: EUS-guided celiac plexus neurolysis for pain in ... Conclusions: Our results show that EUS guided CPN could provide relief in as much as 70% of patients with central neurolysis technique having some edge over ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02682082

EUS Guided Neurolysis Celiac Block w/wo Bupivacaine in ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8221153/

EUS-guided celiac plexus neurolysis for pain in pancreatic ... Conclusions: Our results show that EUS guided CPN could provide relief in as much as 70% of patients with central neurolysis technique having some edge over ...