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}

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2024年10月14日

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C. Mel Wilcox,
Ji Young Bang,
James Buxbaum,
Timothy B. Gardner,
Robert Hawes,
Prashant Kedia,
Samuel H. Mardini,
Thiruvengadam Muniraj,
Udayakumar Navaneethan,
Veeral M. Oza,
Paul Tarnasky,
Shyam Thakkar,
Irving Waxman,
Shyam Varadarajulu,
Akwi Asombang,
Chloe Bennett,
Yan Bi,
Wojciech Blogowski,
Wei-Shen Chin,
Darwin Conwell,
Gregory A. Coté,
Pramod Garg,
Nalini Guda,
Yasmin G. Hernandez-Barco,
Emily Jonica,
Thomas Kowalski,
Vivek Kumbhari,
Linda Lee,
Jorge Machicado,
Desiree Morgan,
Veeral Oza,
Swati Pawa,
Rajesh Puri,
Amit Rastogi,
D. Nageshwar Reddy,
Monica Saumoy,
Mandeep Sawhney,
Santhi Swaroop Vege,
Rupjyoti Talukdar,
Felix Tellez-Avila,
Nikhil Thiruvengadam,
Elaina Vivian,
Field F. Willingham

摘要

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 two-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 1 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.

Trial registration {2}

ClinicalTrials.gov NCT 06178315. Registered on December 21, 2023