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Rome IV Diagnostic Criteria for Functional Biliary Sphincter of Oddi Disorder (SOD)
Diagnostic checklist for functional biliary sphincter of Oddi disorder in adults.
Rome IV Diagnostic Criteria for Functional Biliary Sphincter of Oddi Disorder (SOD)
Biliary-type pain builds up to a steady level
Pain lasts ≥30 minutes
Episodes occur at different intervals, not daily
Pain is severe enough to interrupt daily activities or prompt an emergency visit
Pain is not significantly (<20%) related to bowel movements
Pain is not significantly (<20%) relieved by postural change or acid suppression
No gallstones, biliary sludge, or other structural biliary abnormality identified on evaluation
Transient rise in liver transaminases, ALP, or conjugated bilirubin temporally related to ≥2 pain episodes
Dilated common bile duct on imaging temporally related to pain episodes
ResultCriteria not met
Diagnosis requires the full biliary-pain criteria, exclusion of a structural biliary cause, and either elevated liver enzymes or a dilated common bile duct temporally related to episodes — but not both (both together suggest a structural, not functional, disorder).
- Elevated liver enzymes
- No
- Dilated common bile duct
- No
When to use
- Evaluating recurrent biliary-type pain, typically post-cholecystectomy, once choledocholithiasis and other structural causes are excluded.
Formula
Biliary pain (builds to a steady level, ≥30 min, non-daily, severe enough to interrupt activity/prompt ED visit, <20% related to bowel movements, <20% relieved by posture/acid suppression) plus no structural cause, plus either elevated liver enzymes or a dilated bile duct temporally linked to episodes — not both.
Pearls and pitfalls
- Normal serum amylase/lipase and abnormal sphincter of Oddi manometry or hepatobiliary scintigraphy are supportive but not required for diagnosis.
- If both elevated enzymes and duct dilation are present, consider a structural biliary process instead.