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:
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Atypical symptoms for biliary colic (mild, transient, constant, or daily pain).
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Daily opiate use (can dilate bile ducts).
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Structural diagnosis that explains symptoms (stones, pancreatitis, pancreatic or liver lesion).
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With neither dilated common bile duct nor elevated liver tests.
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With both dilated common bile duct and elevated liver tests.
If typical biliary pain + elevated liver enzymes during episode AND bile duct dilation = definite evidence of biliary obstruction:
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Formerly SOD type I.
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Highest benefit from sphincterotomy.
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SOD manometry not needed given false negatives.
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If on chronic narcotics, could perform initial endoscopic ultrasound to assess for stones/ampullary pathology prior to sphincterotomy.
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Patients are at high risk for post-ERCP pancreatitis and thus advise prophylactic temporary pancreatic stent and use of rectal indomethacin since these can substantially reduce risk.
If typical biliary pain + elevated liver enzymes during episode OR bile duct dilation = suspected biliary obstruction:
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Formerly SOD type II.
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Controversial role for sphincterotomy.
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Best role for SOD manometry if available as can predict response to sphincterotomy.
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Empiric sphincterotomy without manometry found to be cost effective compared to manometry directed sphincterotomy (at the expense of additional procedural risk).
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If the expertise is available, could consider botulinum toxin injection into sphincter of Oddi complex to predict clinical response to sphincterotomy (approach not validated).
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Non-invasive methods exist (magnetic resonance pancreaticocholangiography, hepatobiliary scintigraphy, fatty meal ultrasound) but are not validated.
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Consider neuromodulation (e.g. amitriptyline, duloxetine) or drugs which can lower SOD pressures (e.g. nifedipine, phosphodiesterase type-5 inhibitors, etc) but not validated.
If classic biliary pain + normal liver enzymes during episode AND normal bile ducts = functional biliary pain:
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Formerly SOD type III.
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Advise against sphincterotomy (with or without manometry) given lack of benefit over placebo in sham-controlled trials.
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Reconsider alternative diagnoses such as centrally mediated abdominal pain syndrome.
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Strongly consider neuromodulation (e.g. amitriptyline, duloxetine) or less validated transcutaneous electrical nerve stimulation (TENS) or acupuncture.
This calculator should primarily be used in patients post-cholecystectomy with low clinical suspicion for structural disease with adequate evaluation including liver and pancreatic enzymes, ultrasound and endoscopic ultrasound, or cross-sectional imaging such as magnetic resonance cholangiopancreatography if clinically indicated.
NOTE: other GI conditions such as centrally mediated abdominal pain syndrome, irritable bowel syndrome, and functional dyspepsia may coexist with biliary SOD.