What is the management of biliary pain suspected to be caused by gallstones?

Management of Functional Biliary Pain

For patients with functional biliary pain (biliary-type pain without gallstones), cholecystectomy should be considered only when Rome III criteria are met AND cholecystokinin-cholescintigraphy (CCK-CS) demonstrates a gallbladder ejection fraction (GBEF) <38% using the standardized 60-minute infusion protocol. 1

Diagnostic Criteria and Patient Selection

Rome III Criteria for Functional Gallbladder Disorder

Patients must have episodes of right upper quadrant and/or epigastric pain with ALL of the following characteristics: 1

• Episodes last at least 30 minutes 1
• Recurrent episodes occur at different intervals (not daily) 1
• Pain builds to a steady level 1
• Pain severe enough to interrupt activities or prompt clinical visit 1
• Pain NOT relieved by bowel movements, postural change, or antacids 1
• Other structural diseases excluded 1
• Gallbladder present with no gallstones on ultrasound 1
• Normal liver tests and pancreatic enzymes 1

Supportive Features

The pain may present with: 1

• Nausea and vomiting 1
• Radiation to the back and/or right infrascapular area 1
• Awakening from sleep 1

Mandatory Workup Before CCK-Cholescintigraphy

Before proceeding to CCK-CS, patients must undergo: 1

• Transabdominal ultrasonography to confirm absence of gallstones 1
• Liver function tests and pancreatic enzymes 1
• Upper endoscopy to exclude other causes 1

CCK-Cholescintigraphy Protocol

When to Perform

CCK-CS should only be performed in patients who: 1

• Meet Rome III criteria for functional biliary pain 1
• Are NOT currently experiencing pain 1
• Are NOT hospitalized at the time of study 1
• Are NOT taking interfering medications (opioids, calcium channel blockers, oral contraceptives, H2-receptor antagonists, benzodiazepines) 1

Standardized Testing Protocol

The only validated protocol uses: 1

• Sincalide dose: 0.02 μg/kg (total dose 1.4 μg for 70 kg patient) 1
• Infusion duration: 60 minutes (NOT shorter durations) 1
• Normal GBEF cutoff: ≥38% 1
• Abnormal GBEF: <38% is consistent with functional gallbladder disorder 1

Treatment Algorithm

For GBEF <38% with Rome III Criteria

Cholecystectomy is recommended, as current expert consensus favors surgery for patients with biliary pain and abnormal GBEF. 1 However, the evidence base remains limited and a large prospective randomized controlled trial is still needed. 1

For GBEF ≥38% or Atypical Symptoms

Cholecystectomy should NOT be performed. 1 Patients with atypical symptoms (indigestion, flatulence, heartburn, bloating, belching, nausea alone) are less likely to benefit from cholecystectomy, and CCK-CS does not add to clinical judgment in predicting surgical outcomes for these patients. 2

Critical Pitfalls to Avoid

Patient Selection Errors

Do NOT perform CCK-CS in patients with: 1

• Atypical symptoms that don't meet Rome III criteria 1
• Active pain at time of testing 1
• Use of interfering medications 1

An abnormal GBEF is NOT specific for functional gallbladder disorder and may occur in: 1

• Diabetes mellitus 1
• Celiac disease 1
• Irritable bowel syndrome 1
• Asymptomatic healthy individuals 1

Technical Errors

Do NOT use non-standardized protocols. 1 Infusion durations shorter than 60 minutes, different doses, or bolus administration produce unreliable results that cannot be compared to validated cutoff values. 1

Interpretation Errors

CCK-induced pain during the test does NOT have proven diagnostic value and should not be used to guide treatment decisions. 1 The development of symptoms following sincalide infusion may not reflect the presence of gallbladder disease. 1

Anatomic Considerations

The gallbladder may not be responsible for a decreased GBEF. 1 Occasionally, outflow obstruction from cystic duct abnormalities or sphincter of Oddi dysfunction may be the actual cause. 1

Expected Outcomes

Approximately 30% of patients with a single episode of biliary pain may not experience additional episodes even without treatment. 2 This natural history should be discussed with patients when considering cholecystectomy for functional biliary pain.

Persistent dyspeptic symptoms occur frequently following cholecystectomy in patients with atypical presentations. 2 A prolonged history of dyspeptic symptoms prior to surgery predicts unsatisfactory surgical outcomes. 3