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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.

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

Diagnostic Result

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Advice

If diagnostic criteria for typical biliary pain met + presence of gallstones or other structural pathology (positive):

  • If gallbladder is present, refer to surgery for possible cholecystectomy.

  • If gallbladder is absent, consider EUS +/- endoscopic retrograde cholangiopancreatography (ERCP). 

If diagnostic criteria for typical biliary pain met + absence of gallstones, elevated liver enzymes and/or bile duct dilation:

If diagnostic criteria for typical biliary pain NOT met + absence of gallstones or other structural pathology (negative):

  • Consider alternative diagnoses for gastrointestinal pain.

Management

Management should be based on the presence or absence of a gallbladder, gallstones/sludge or other structural pathology.

Functional Gallbladder Disorder (gallbladder present):

  • Symptoms often resolve spontaneously, advise reassurance.

  • Anti-spasmodics, neuromodulators, or ursodeoxycholic acid.

Sphincter of Oddi Disorder (gallbladder absent):

  • If liver enzymes are elevated during an episode AND the bile duct dilation not due to other causes (i.e. opiates): 

    • Consistent with biliary stenosis.

    • Consider sphincterotomy.

  • If liver enzymes are elevated during an episode OR the bile duct dilation:

    • Consistent with functional biliary SOD.

    • Can consider sphincterotomy but risks often outweigh benefits.

    • Consider neuromodulation such as tricyclic antidepressants.

  • If liver enzymes are normal during an episode AND the bile duct is not dilated:

    • Consistent with functional biliary-type pain.

    • Avoid sphincterotomy as proven risks outweigh benefits.

    • Reassurance +/- neuromodulation advised.

Consult Rome IV Criteria on Gallbladder and Biliary Disorders for further details.

Critical Actions

  • This calculator should only be used for patients with low clinical suspicion for structural disease and adequate evaluation including liver and pancreatic enzymes, ultrasound, and possibly EUS if clinically indicated.

  • Other GI conditions such as irritable bowel syndrome and functional dyspepsia may coexist with functional gallbladder disorder, sphincter of Oddi disorder, or functional biliary-type pain.

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