NCT06178315 · Orlando Health, Inc.
EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis
(EPOCH)
What this study is about
The aim of this randomly assigned trial is to assess the effectiveness of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.
View original scientific description
The aim of this randomized trial is to assess the efficacy of EUS-CPB in the alleviation of abdominal pain in patients with chronic pancreatitis.
Interventions
PROCEDURE
EUS-guided celiac plexus block
Under EUS-guidance, celiac plexus block will be performed with injection of bupivacaine and triamcinolone into the area of celiac plexus.
PROCEDURE
Sham procedure
Celiac plexus will not be performed in this arm.
Primary outcome measures
Rate of adequate pain relief
Time frame: 1 month
Rate of adequate pain relief in patients with chronic pancreatitis undergoing endoscopic ultrasound-guided celiac plexus block or sham procedure. Adequate pain relief is defined as a 50% reduction in composite pain score from baseline, measured using the Brief Pain Inventory-Short Form, at 1 month post-intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years
- Abdominal pain of at least 3 months duration and a VAS score ≥ 3, with or without the use of narcotic analgesics.
- Diagnosis of chronic pancreatitis on EUS examination, with ≥ 5 features on EUS.
- No other cause of abdominal pain
Exclusion criteria
- Age \< 18 years.
- History of prior EUS-CPB.
- Use of anticoagulants that cannot be discontinued for the procedure.
- Clinically significant allergy to bupivacaine or triamcinolone.
- Unable to obtain consent for the procedure from either the patient or LAR.
- Intrauterine pregnancy.
Where
- Orlando, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 21, 2023 · Source of record for eligibility and locations