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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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Trial Charles Melbern Wilcox, Ji Young Bang, Timothy B. Gardner, Robert Hawes, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4213055/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 14 Oct, 2024 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background Celiac plexus block has been commonly utilized for the treatment of chronic pancreatitis associated abdominal pain. Prospective studies suggest efficacy in 30 to 50% of patients, although no randomized sham-controlled trials have been performed. The objective of this study is to assess the effect of endoscopic ultrasound (EUS)-guided celiac plexus block on abdominal pain in patients with documented chronic pancreatitis. Methods This is a 2-arm randomized sham-controlled trial with blinded evaluators. The study will be conducted at multiple academic sites in the United States who are members of the United States Pancreatic Disease Study Group (USPG). Patients referred for EUS to exclude chronic pancreatitis as a cause of abdominal pain as well as those with established painful chronic pancreatitis undergoing EUS for another indication will be eligible. At the time of EUS with confirmation of chronic pancreatitis by standard EUS diagnostic criteria, patients will be randomized to either celiac plexus block or sham whereby an anesthetic and steroid combination will be injected into the celiac plexus or saline will be injected into the gastric lumen with the same type of needle as used for celiac plexus block, respectively. The main outcome measure will be a 50% reduction in abdominal pain using the Brief Pain Inventory Short Form (BPI-SF) at one month post intervention. A number of secondary outcomes will be measured including visual analog scale (VAS), Comprehensive Pain Assessment Tool-Short Form (COMPAT-SF) pain scores and quality of life using a pancreas-specific validated measure (PANQOLI). Discussion In this study, the effect of celiac plexus block on abdominal pain in patients with chronic pancreatitis will be compared to a sham intervention. This randomized trial will offer a definitive assessment of the role of celiac plexus block for the treatment of abdominal pain in this setting. Chronic pancreatitis celiac plexus block abdominal pain endoscopic ultrasonography Full Text Cite Share Download PDF Status: Published Journal Publication published 14 Oct, 2024 Read the published version in Trials → Version 1 posted Editorial decision: Major revision 07 Aug, 2024 Reviewers agreed at journal 26 Jul, 2024 Reviewers invited by journal 26 Jul, 2024 Editor assigned by journal 09 May, 2024 First submitted to journal 26 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4213055","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":332207206,"identity":"a70758e5-318b-491f-816d-0443909921fc","order_by":0,"name":"Charles Melbern Wilcox","email":"data:image/png;base64,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","orcid":"","institution":"Orlando Health","correspondingAuthor":true,"prefix":"","firstName":"Charles","middleName":"Melbern","lastName":"Wilcox","suffix":""},{"id":332207207,"identity":"06860d75-f95d-4497-9188-e23ded436593","order_by":1,"name":"Ji Young Bang","email":"","orcid":"","institution":"Orlando Health Corp: Orlando Health","correspondingAuthor":false,"prefix":"","firstName":"Ji","middleName":"Young","lastName":"Bang","suffix":""},{"id":332207208,"identity":"a4e57f40-12e9-4b3b-b322-830d7ee4f2b6","order_by":2,"name":"Timothy B. 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