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Procedure
Endoscopic ultrasound-guided 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
EPOCH Trial 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.Check my eligibility
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.See study design
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.
EPOCH Trial 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.
EPOCH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of adequate pain relief
Secondary outcome measures
Disease-related adverse events
Hospital admissions for management of chronic pancreatitis.
Length of hospitalization in any patient hospitalized
+8 moreEPOCH Trial 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.
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Who is running the clinical trial?
Orlando Health, Inc.Lead Sponsor
28 Previous Clinical Trials
12,649 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment for this study currently available to prospective participants?
"Indeed, as per the information provided by clinicaltrials.gov, this study is currently in the active recruitment phase. The trial was initially posted on December 7th, 2023 and underwent its most recent update on December 18th, 2023."
Answered by AI
How many individuals in total are involved as participants in this research investigation?
"Indeed, the information provided on clinicaltrials.gov confirms that this particular clinical trial is actively seeking individuals to participate. It was originally posted on December 7th, 2023 and recently updated on December 18th, 2023. The study aims to recruit a total of 94 participants from a single designated site."
Answered by AI
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