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}

doi:10.1186/s13063-024-08478-y

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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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 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.

Original language	English
Article number	676
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-024-08478-y
State	Published - Dec 2024

Bibliographical note

Publisher Copyright:
© The Author(s) 2024.

Funding

Not applicable. Members of the US Pancreatic Disease Study Group C. Mel Wilcox, MD1, Ji Young Bang, MD1, Akwi Asombang, MD2, Chloe Bennett, MD3, Yan Bi, MD4, Wojciech Blogowski, MD5,6, James Buxbaum, MD7, Wei-Shen Chin, MD8, Darwin Conwell, MD9, Gregory A. Coté, MD10, Timothy B. Gardner, MD11, Pramod Garg, MD12, Nalini Guda, MD13, Robert Hawes, MD1, Yasmin G. Hernandez-Barco, MD2, Emily Jonica, MD10, Prashant Kedia, MD14, Thomas Kowalski, MD15, Vivek Kumbhari, MD4, Linda Lee, MD16, Jorge Machicado, MD17, Desiree Morgan, MD18, Thiruvengadam Muniraj, MD3, Udayakumar Navaneethan, MD1, Veeral Oza, MD19, Swati Pawa, MD20, Rajesh Puri, MD21, Amit Rastogi, MD22, D. Nageshwar Reddy, MD23, Monica Saumoy, MD24, Mandeep Sawhney, MD25, Santhi Swaroop Vege, MD26, Rupjyoti Talukdar, MD23, Paul Tarnasky, MD14, Felix Tellez-Avila, MD27, Shyam Thakkar, MD28, Nikhil Thiruvengadam, MD29, Elaina Vivian, MPH14, Irving Waxman, MD5, Field F. Willingham, MD30, Shyam Varadarajulu, MD1 1Digestive Health Institute, Orlando Health, Orlando, FL; 2Harvard, Massachusetts General Hospital, Boston, MA; 3Yale School of Medicine, New Haven, CT; 4Mayo Clinic, Jacksonville, FL; 5Rush University Medical Center, Chicago, IL; 6University of Zielona Gora, Poland; 7Keck Medicine of USC, Los Angeles, CA; 8Department of Radiology, Orlando Health, Orlando, FL; 9University of Kentucky College of Medicine, Lexington, KY; 10Oregon Health & Science University, Portland, OR; 11Dartmouth Geisel School of Medicine, Hanover, NH; 12Department of Gastroenterology at All India Institute of Medical Sciences, New Delhi, India; 13Aurora Health Care, Milwaukee, WI; 14Methodist Health, Dallas, TX; 15Jefferson Health, Philadelphia, PA; 16Harvard, Brigham and Women’s Hospital, Boston, MA; 17University of Michigan, Ann Arbor, MI; 18Department of Radiology, University of Alabama, Birmingham, AL; 19Prizma Health, Greenville, SC; 20Wake Forest University School of Medicine, NC; 21Institute of Digestive & Hepatobiliary Sciences, Medanta, Gurgaon, Haryana, India; 22University of Kansas Medical Center, Kansas City, KS; 23Asian Institute of Gastroenterology, Hyderabad, India; 24Penn Medicine Princeton Medical Center, Philadelphia, PA; 25Beth Israel Deaconess Hospital, Boston, MA; 26Mayo Clinic, Rochester, MN; 27University of Arkansas Medical System, Little Rock, AR; 28West Virginia University, Morgantown, WV; 29Loma Linda University Health, Loma Linda, CA; 30Emory University Department of Medicine, Atlanta, GA.

Funders	Funder number
30Emory University Department of Medicine, Atlanta
University of Alabama
Department of Radiology, Weill Cornell Medicine
28West Virginia University
Massachusetts General Hospital
Kentucky College of Osteopathic Medicine
South China Normal University
US Pancreatic Disease Study Group C. Mel Wilcox
12Department of Gastroenterology at All India Institute of Medical Sciences

Keywords

Abdominal pain
Celiac plexus block
Chronic pancreatitis
Endoscopic ultrasonography

ASJC Scopus subject areas

Medicine (miscellaneous)
Pharmacology (medical)

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10.1186/s13063-024-08478-y

Cite this

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title = "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\}",

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 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.",

keywords = "Abdominal pain, Celiac plexus block, Chronic pancreatitis, Endoscopic ultrasonography",

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

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = dec,

doi = "10.1186/s13063-024-08478-y",

language = "English",

volume = "25",

number = "1",

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TY - JOUR

T1 - Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial)

T2 - study protocol for a randomized multicenter sham-controlled trial {1}

AU - Wilcox, C. Mel

AU - Bang, Ji Young

AU - Buxbaum, James

AU - Gardner, Timothy B.

AU - Hawes, Robert

AU - Kedia, Prashant

AU - Mardini, Samuel H.

AU - Muniraj, Thiruvengadam

AU - Navaneethan, Udayakumar

AU - Oza, Veeral M.

AU - Tarnasky, Paul

AU - Thakkar, Shyam

AU - Waxman, Irving

AU - Varadarajulu, Shyam

AU - Willingham, Field F.

AU - Vivian, Elaina

AU - Thiruvengadam, Nikhil

AU - Tellez-Avila, Felix

AU - Talukdar, Rupjyoti

AU - Vege, Santhi Swaroop

AU - Sawhney, Mandeep

AU - Saumoy, Monica

AU - Reddy, D. Nageshwar

AU - Rastogi, Amit

AU - Puri, Rajesh

AU - Pawa, Swati

AU - Oza, Veeral

AU - Morgan, Desiree

AU - Machicado, Jorge

AU - Lee, Linda

AU - Kumbhari, Vivek

AU - Kowalski, Thomas

AU - Jonica, Emily

AU - Hernandez-Barco, Yasmin G.

AU - Guda, Nalini

AU - Garg, Pramod

AU - Coté, Gregory A.

AU - Conwell, Darwin

AU - Chin, Wei Shen

AU - Blogowski, Wojciech

AU - Bi, Yan

AU - Bennett, Chloe

AU - Asombang, Akwi

PY - 2024/12

Y1 - 2024/12

N2 - 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.

AB - 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.

KW - Abdominal pain

KW - Celiac plexus block

KW - Chronic pancreatitis

KW - Endoscopic ultrasonography

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UR - https://www.scopus.com/inward/citedby.url?scp=85206275885&partnerID=8YFLogxK

U2 - 10.1186/s13063-024-08478-y

DO - 10.1186/s13063-024-08478-y

M3 - Article

C2 - 39396987

AN - SCOPUS:85206275885

SN - 1745-6215

VL - 25

JO - Trials

JF - Trials

IS - 1

M1 - 676

ER -

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}

Abstract

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ASJC Scopus subject areas

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