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Status unknownNCT05587933Updated Oct 20, 2022

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

An interventional study of cholecystectomy and Antispasmodic in Gall Bladder Pain, Hepatobiliary Iminodiacetic Acid and Acalculous Cholecystitis, sponsored by Assiut University. Status unknown. Open to participants aged 12 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-20.

Sponsored by Assiut University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
12 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gall Bladder Pain
  • Hepatobiliary Iminodiacetic Acid
  • Acalculous Cholecystitis
03

In context

Cholecystitis

266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.

This study's planned enrollment of 20 is below the median of 86 across 167 interventional studies indexed under Cholecystitis.

Browse Cholecystitis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    operative

    Procedure: cholecystectomy · Drug: Antispasmodic

Interventions

  • Procedurecholecystectomy

    cholecystectomy

  • DrugAntispasmodic

    Antispasmodic

06

What researchers measure

Primary outcomes

  1. Rate of quality of life improvment after cholecystectomy according to ROME IV criteria

    abdominal pain, nausea and vomiting

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05587933
Lead sponsor
Assiut University
Responsible party
Ahmed Yassien Abd-Elkariem (General surgery resident, Assiut University) — Principal investigator
First posted
Oct 20, 2022
Start date
Oct 25, 2022 (estimated)
Primary completion
May 1, 2023 (estimated)
Completion
Jul 1, 2023 (estimated)
Last update
Oct 20, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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