EUS-guided Celiac Plexus Block vs. Sham in Chronic Pancreatitis
NCT ID: NCT06178315
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
94 participants
INTERVENTIONAL
2023-12-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Endoscopic ultrasound-guided celiac plexus block
EUS-guided celiac plexus block will be performed.
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.
Sham
Celiac plexus block will not be performed.
Sham procedure
Celiac plexus will not be performed in this arm.
Interventions
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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.
Sham procedure
Celiac plexus will not be performed in this arm.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Orlando Health, Inc.
OTHER
Responsible Party
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Locations
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Orlando Health
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Wilcox CM, Bang JY, Buxbaum J, Gardner TB, Hawes R, Kedia P, Mardini SH, Muniraj T, Navaneethan U, Oza VM, Tarnasky P, Thakkar S, Waxman I, Varadarajulu S; US Pancreatic Disease Study Group. Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial 1. Trials. 2024 Oct 14;25(1):676. doi: 10.1186/s13063-024-08478-y.
Other Identifiers
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2103069
Identifier Type: -
Identifier Source: org_study_id
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