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Procedure
Celiac Plexus Block for Chronic Pancreatitis (EPOCH Trial)
N/A
Recruiting
Research Sponsored by Orlando Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Abdominal pain of at least 3 months duration and a VAS score ≥ 3, with or without the use of narcotic analgesics.
Must not have
History of prior EUS-CPB.
Use of anticoagulants that cannot be discontinued for the procedure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Summary
This trial is testing if a procedure called EUS-CPB can help reduce abdominal pain in people with chronic pancreatitis.
Who is the study for?
This trial is for adults over 18 with chronic pancreatitis, experiencing abdominal pain for at least three months. They must have a confirmed diagnosis of chronic pancreatitis via EUS and no other causes for their pain. It's not open to those under 18, anyone who has had this procedure before, pregnant individuals, patients on certain blood thinners or with allergies to specific anesthetics.
What is being tested?
The study is testing the effectiveness of an EUS-guided celiac plexus block (EUS-CPB) in reducing abdominal pain against a sham (fake) procedure. Participants are randomly assigned to receive either the real treatment or a placebo-like intervention without therapeutic effect.
What are the potential side effects?
While the document doesn't specify side effects, generally procedures like EUS-CPB can cause soreness where the needle was inserted, bleeding, infection risk and potential allergic reactions to medications used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have had abdominal pain for 3 months or more, with a pain level of 3 or higher.
Select...
My chronic pancreatitis diagnosis was confirmed with an EUS showing 5 or more features.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a previous EUS-CPB procedure.
Select...
I am on blood thinners that can't be stopped for a procedure.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of adequate pain relief
Secondary study objectives
Disease-related adverse events
Hospital admissions for management of chronic pancreatitis.
Length of hospitalization in any patient hospitalized
+8 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Endoscopic ultrasound-guided celiac plexus blockActive Control1 Intervention
EUS-guided celiac plexus block will be performed.
Group II: ShamPlacebo Group1 Intervention
Celiac plexus block will not be performed.
Find a Location
Who is running the clinical trial?
Orlando Health, Inc.Lead Sponsor
31 Previous Clinical Trials
15,023 Total Patients Enrolled