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    Rome IV Diagnostic Criteria for Functional Biliary Sphincter of Oddi Disorder (SOD)

    Official Rome IV criteria for the diagnosis of functional biliary sphincter of Oddi disorder.


    Use in patients post-cholecystectomy with symptoms characteristic of typical biliary pain as defined by Rome IV criteria with elevated liver enzymes or dilated common bile duct, but NOT both. Supportive criteria such as normal amylase/lipase, abnormal sphincter of Oddi (SOD) manometry, or abnormal hepatobiliary scintigraphy can aid in diagnosis if available.

    Do NOT use these criteria in patients with:

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

    • Daily opiate use (can dilate bile ducts).

    • Structural diagnosis that explains symptoms (stones, pancreatitis, pancreatic or liver lesion).

    • With neither dilated common bile duct nor elevated liver tests.

    • With both dilated common bile duct and elevated liver tests.

    When to Use
    Why Use

    Use in patients post-cholecystectomy with symptoms characteristic of typical biliary pain as defined by Rome IV criteria with elevated liver enzymes or dilated common bile duct, but NOT both.

    • Developed to select patients who would most benefit from biliary sphincterotomy.

    • Advise against using criteria to direct therapy in patients with intact gallbladders without stones.

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

    • Critical to document objective evidence of elevated liver enzymes during episode and/or dilated bile ducts as their presence/absence can direct significantly different treatments.

    • Chronic narcotic use can lead to opioid induced hyperalgesia as well as dilated bile ducts, thus clinicians should consider alternative diagnosis in these patients.

    • Bile duct often dilates post-cholecystectomy due to reservoir effect, though high suspicion if ≥1 cm.

    • Helps objectively delineate diagnosis in condition with considerable controversy.

    • May help direct extremely different treatment strategies (e.g. sphincterotomy versus neuromodulation).

    • Provides guidance for patient selection in important shared decision-making conversations with patients on potentially high-risk procedures such as sphincterotomy.

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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