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Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?

A

Assiut University

Status

Not yet enrolling

Conditions

Gall Bladder Pain
Acalculous Cholecystitis
Hepatobiliary Iminodiacetic Acid

Treatments

Procedure: cholecystectomy
Drug: Antispasmodic

Study type

Interventional

Funder types

Other

Identifiers

NCT05587933
GB EF biliary colic normal US

Details and patient eligibility

About

In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy.

Full description

The flow of bile through the biliary system is a complex process that depends on the hormonal environment, digestive phase, and functional response of the gallbladder and sphincter of Oddi to all of these factors. Biliary dyskinesia is a disorder of some component of biliary part of the digestive system in which bile cannot physically flow in the proper direction through the tubular biliary tract which causes biliary colic as defined by Rome IV criteria.

Functional causes of biliary pain, also referred to as biliary dyskinesia, are biliary hypokinesia , biliary hyperkinesia and sphincter of Oddi dysfunction (SOD). The exact pathology of functional biliary colic is still unknown. Reviewing Literature status, There is still some debate about the best method to establish the diagnosis gallbladder dyskinesia and hyperkinesia and whether or not ejection fraction is an accurate predictor of outcome. Which led to difficult.

Biliary dyskinesia is identified through gallbladder ejection fraction (GBEF), which is calculated as the flow of radioactive tracer that is ejected from the gallbladder. A GBEF of <35% is considered dyskinesia and a GBEF of <35% is considered hyperkinesia. Patients considered for CCK-HIDA (cholecystokinin hepatobiliary iminodiacetic acid) are those presenting with functional biliary pain based on the Rome IV criteria. Those who present with atypical pain may not need as HIDA (hepatobiliary iminodiacetic acid) as the presentation may be from other pathology.

Enrollment

20 estimated patients

Sex

All

Ages

12 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients older than 14 years of age
  • food-related abdominal pain
  • normal gallbladder ultrasound (US)
  • GB EF 80% and greater or 35% and less on HIDA scan with CCK injection

Exclusion criteria

  • Patients younger than 14 years old
  • Patients with the positive US defined as the presence of gallstones, gallbladder wall thickening (> 4 mm), pericholecystic fluid, sludge, or polyps
  • Normal GB EF

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

operative
Experimental group
Treatment:
Drug: Antispasmodic
Procedure: cholecystectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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