What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer include systemic therapies like FOLFIRINOX and gemcitabine, which inhibit cancer cell growth by interfering with DNA replication and cell division. Targeted therapies, such as PARP inhibitors for BRCA-mutated cancers, disrupt specific molecular pathways essential for cancer cell survival. Pain management techniques, such as celiac plexus neurolysis (CPN) using alcohol, aim to destroy nerves transmitting pain signals. These mechanisms are vital for tailoring treatments to individual genetic profiles and effectively managing symptoms, improving the quality of life for pancreatic cancer patients.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as EUS-guided celiac plexus neurolysis (EUS-CPN), can cause side effects including transient pain at the injection site, potential for inadvertent intravascular injection leading to severe complications like cardiac arrhythmias, and possible long-term pain control issues. Chemotherapy, another common treatment, often results in side effects like nausea, vomiting, fatigue, peripheral neuropathy, and increased risk of infection. High-intensity focused ultrasound (HIFU) is generally well-tolerated but can cause local skin burns and discomfort. These treatments aim to manage pain and improve quality of life but come with varying degrees of side effects that need to be managed carefully.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer include systemic chemotherapy regimens such as FOLFIRINOX (a combination of leucovorin, fluorouracil, irinotecan, and oxaliplatin) and gemcitabine plus nab-paclitaxel. These treatments are used to improve symptoms and prolong survival in patients with advanced pancreatic cancer. Additionally, neoadjuvant therapies, including gemcitabine-based chemoradiotherapy and FOLFIRINOX, are employed for potentially resectable pancreatic cancer to increase resection rates and improve outcomes. These regimens are relevant to the trial assessing the exclusion of bupivacaine, as they represent the current standard of care for managing pancreatic cancer and associated pain.

What other types of research exist?

Promising alternatives to the exclusion of bupivacaine for pancreatic cancer patients include the use of liposomal bupivacaine for prolonged pain relief, topical menthol for neuropathic pain, and integrative therapies such as biofeedback and mindfulness-based interventions. These options should be discussed with a healthcare provider to tailor the best pain management strategy for individual patients.

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EUS-CPN With vs Without Bupivacaine for Pancreatic Cancer (EUS-NB Trial)

N/A

Recruiting

Led By ANAND V SAHAI, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include discomfort during and after the procedure, possible dilution of alcohol's effect if mixed with bupivacaine, and serious risks like irreversible heart rhythm problems if bupivacaine accidentally enters blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is in the middle or end parts of the pancreas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Likert pain scores

Secondary study objectives

Adverse events

Difference in Global Rating Scale of Change at T3 vs all other follow-up time points

Difference in pain scores at T0 vs all other follow-up time points

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EUS-CPN without bupivacaineExperimental Treatment1 Intervention

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

Group II: EUS-CPN with bupivacaineActive Control1 Intervention

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer include systemic therapies like FOLFIRINOX and gemcitabine, which inhibit cancer cell growth by interfering with DNA replication and cell division. Targeted therapies, such as PARP inhibitors for BRCA-mutated cancers, disrupt specific molecular pathways essential for cancer cell survival. Pain management techniques, such as celiac plexus neurolysis (CPN) using alcohol, aim to destroy nerves transmitting pain signals. These mechanisms are vital for tailoring treatments to individual genetic profiles and effectively managing symptoms, improving the quality of life for pancreatic cancer patients.