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    Rome IV Diagnostic Criteria for Functional Gallbladder Disorder

    Official Rome IV criteria for the diagnosis of functional gallbladder disorder.


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

    Supportive criteria such as low ejection fraction on gallbladder scintigraphy (<40%) and normal liver enzymes, conjugated bilirubin, and amylase/lipase can aid in diagnosis.

    Do NOT use these criteria in patients with:

    • Atypical symptoms for biliary colic (mild, transient, constant, daily).

    • Visualized cholelithiasis or microlithiasis/sludge on ultrasound or endoscopic ultrasound (EUS).

    • Structural abnormalities, especially biliary dilation or liver enzymes not explained by other cause: should consider EUS or magnetic resonance cholangiopancreaticography (MRCP).

    When to Use
    Why Use

    Use in patients with symptoms characteristic of typical biliary pain as defined by Rome IV criteria with gallbladder present without biliary dilation or unexplained liver enzyme abnormality. If symptoms are atypical for biliary pain, consider other causes for gastrointestinal pain.

    • Critical to obtain a detailed history of the pain pattern which is consistent with typical biliary pain criteria.

    • If the pain pattern is not consistent with typical biliary pain, should investigate other causes.

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

    • Overlap exists between functional gallbladder disorder and other functional GI disorders. 

    • With repeated episodes of biliary pain, consider microlithiasis.

    • Sphincter of Oddi disorder is typically and most commonly diagnosed when the gallbladder is absent. However, biliary dilatation or enzyme elevation is consistent with sphincter of Oddi disorder when the gallbladder is present.

    • Identification of functional gallbladder disorder may lead to cholecystectomy given the right clinical context.

    • Symptoms of typical or atypical biliary pain may be treated with other options including anti-spasmodics, neuromodulation, or ursodeoxycholic acid.

    • There is conflicting evidence on the utility of gallbladder ejection fraction in predicting outcomes post-cholecystectomy.

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    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