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    Rome IV Diagnostic Criteria for Biliary Pain

    Official Rome IV criteria for the diagnosis of biliary pain.


    Use in patients with symptoms characteristic of typical biliary pain as defined by Rome IV criteria.

    If gallbladder present:

    • Supportive criteria such as low ejection fraction on gallbladder scintigraphy and normal liver transaminases, conjugated bilirubin, and amylase/lipase can aid in diagnosis of functional gallbladder disorder.

    If gallbladder absent:

    Supportive criteria such as normal amylase/lipase, abnormal sphincter of Oddi (SOD) manometry, or abnormal hepatobiliary scintigraphy can aid in diagnosis of sphincter of Oddi disorder.

    When to Use
    Why Use

    Use in patients with symptoms characteristic of typical biliary pain as defined by Rome IV criteria. Whether the gallbladder is present or absent, one must obtain liver and pancreatic enzymes and imaging such as right upper quadrant ultrasound and sometimes endoscopic ultrasound (EUS) to rule out structural causes including microlithiasis and/or biliary dilation.

    • Pain does not need to be localized to the right upper quadrant (frequently epigastric, non-radiating).

    • If the gallbladder is not present and biliary pain occurs, evaluate for common bile duct dilation and elevated liver enzymes.

      • If both are abnormal, consider bile duct stricture.

      • If one is abnormal, treat for Sphincter of Oddi disorder.

      • If both are normal, treat for functional biliary pain.

    • If pattern is not consistent with typical biliary pain, investigate other causes such as functional dyspepsia and irritable bowel syndrome.

    • Supportive criteria for biliary pain include nausea vomiting, radiation to the back and/or right infrasubscapular region, and waking from sleep because of the pain.

    • If typical biliary pain occurs post-cholecystectomy, it is critical to document objective evidence of elevated liver enzymes during an episode and/or dilated bile ducts as these findings can direct treatment towards sphincterotomy rather than neuromodulators. 

    • Chronic narcotic use can lead to opioid induced hyperalgesia as well as dilated bile ducts, that would mimic biliary pain. 

    • The bile duct may dilate post-cholecystectomy due to a reservoir effect. However, consider bile duct obstruction if >1cm.

    • Biliary Sphincter of Oddi disorder (SOD) differs from Pancreatic Sphincter of Oddi disorder which is considered in patients with documented acute recurrent pancreatitis.

    • Helps objectively delineate functional biliary and pancreatic diagnoses (e.g. functional gallbladder disorder, sphincter of Oddi disorder, or functional biliary pain).

    • May help direct treatment strategies (e.g. cholecystectomy, sphincterotomy, and/or neuromodulation).

    Must have pain located in the epigastrium and/or right upper quadrant and all of the following:

    Diagnostic Result:

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    Next Steps
    Creator Insights
    Dr. Douglas Drossman

    About the Creator

    Douglas Drossman, MD, is professor emeritus of medicine and psychiatry at the University of North Carolina School of Medicine. He is founder, President Emeritus and Chief of Operations of the Rome Foundation. He is also the founder of the Drossman Center for the Education and Practice of Biopsychosocial Care and Drossman Consulting, LLC. Dr. Drossman has written over 500 articles and book chapters, has published two books, a GI procedure manual and a textbook of functional GI disorders (Rome I-IV), and serves on six editorial and advisory boards.

    To view Dr. Douglas Drossman's publications, visit PubMed

    Dr. Lin Chang

    About the Creator

    Lin Chang, MD is responsible for the oversight and coordination of the Rome IV calculators on MDCalc. She is a Professor of Medicine at the Vatche and Tamar Manoukian Division of Digestive Diseases at UCLA and is a member of the Rome Foundation Board of Directors.

    To view Dr. Lin Chang's publications, visit PubMed

    The Rome Foundation

    About the Creator

    The Rome Foundation is an independent not for profit 501(c) 3 organization that provides support for activities designed to create scientific data and educational information to assist in the diagnosis and treatment of Disorders of Gut-Brain Interaction (DGBI), also known as functional gastrointestinal (GI) disorders. Their mission is to improve the lives of people with DGBI. Over the last 3 decades, the Rome organization has sought to legitimize and update our knowledge of the DGBIs. This has been accomplished by bringing together scientists and clinicians from around the world to classify and critically appraise the science of GI function and dysfunction. This knowledge permits clinical scientists to make recommendations for diagnosis and treatment that can be applied in research and clinical practice. Diagnosis is based on the use of symptom-based criteria which are used in clinical trials and daily practice. The list of Rome IV categories and the Chair and Co-Chair of each chapter committee are listed below.

    Committees Chair Co-Chair
    Esophageal Disorders Ronnie Fass, MD John Pandolfino, MD
    Gastroduodenal Disorders Nicholas J. Talley, MD, PhD, FRACP Vincenzo Stanghellini, MD
    Bowel Disorders Fermin Mearin, MD Brian Lacy, MD, PhD
    Gallbladder and Sphincter of Oddi Disorders Grace Elta, MD Peter Cotton, MD
    Centrally Mediated Disorders of Gastrointestinal Pain Peter J. Whorwell, MD Laurie Keefer, PhD
    Anorectal Disorders Adil E. Bharucha, MD, MBBS Satish S. C. Rao, MD, PhD, FRCP
    Childhood Functional Gastrointestinal Disorders: Neonate/Toddler Sam Nurko, MD Marc A. Benninga, MD
    Childhood Functional Gastrointestinal Disorders: Child/Adolescent Carlo Di Lorenzo, MD Jeffrey S. Hyams, MD

    Rome IV Diagnostic Criteria Chapters, Chairs and Co-Chairs

    Rome IV Editorial Board: Douglas A. Drossman, MD, Senior Editor, Lin Chang, MD, William D. Chey, MD, John Kellow, MD, Jan Tack, MD, PhD, and William E. Whitehead, PhD.

    To view The Rome Foundation's publications, visit PubMed

    Content Contributors
    • Justin Brandler, MD
    Reviewed By
    • Jan Track, MD, PhD, RFF
    About the Creator
    Dr. Douglas Drossman
    Dr. Lin Chang
    The Rome Foundation
    Content Contributors
    • Justin Brandler, MD
    Reviewed By
    • Jan Track, MD, PhD, RFF