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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05587933
Enrollment
20
Registered
2022-10-20
Start date
2022-10-25
Completion date
2023-07-01
Last updated
2022-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acalculous Cholecystitis, Gall Bladder Pain, Hepatobiliary Iminodiacetic Acid

Brief summary

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

Detailed 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.

Interventions

PROCEDUREcholecystectomy

cholecystectomy

DRUGAntispasmodic

Antispasmodic

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of quality of life improvment after cholecystectomy according to ROME IV criteria6 monthsabdominal pain, nausea and vomiting

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026