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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
EUS-NB Trial Summary
This trial will compare the outcomes of EUS-guided CPN with and without bupivacaine.
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.Check my eligibility
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.See study design
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.
EUS-NB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in the middle or end parts of the pancreas.
EUS-NB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Likert pain scores
Secondary outcome measures
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 moreEUS-NB 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%.
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,457 Total Patients Enrolled
ANAND V SAHAI, MDPrincipal InvestigatorCentre de Recherche du Centre Hospitalier de l'Université de Montréal
1 Previous Clinical Trials
108 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.My cancer is in the middle or end parts of the pancreas.You are allergic to bupivacaine.
Research Study Groups:
This trial has the following groups:- Group 1: EUS-CPN with bupivacaine
- Group 2: EUS-CPN without bupivacaine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this research project?
"Affirmative, clinicaltrials.gov's records demonstrate that this medical research has been ongoing since its initial posting on October 7th 2021 and is still actively seeking participants. The trial seeks 180 patients from a single site for enrolment."
Answered by AI
Are enrollees still being accepted for participation in this research?
"This clinical trial is actively searching for volunteers. It was initially made available on October 7th 2021 and has since been subject to regular updates, with the latest one taking place earlier this month (October 11th 2022)."
Answered by AI
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