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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05587933
Collaborator
(none)
20
1
8.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?
Anticipated Study Start Date :
Oct 25, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: operative

Procedure: cholecystectomy
cholecystectomy

Drug: Antispasmodic
Antispasmodic

Outcome Measures

Primary Outcome Measures

  1. Rate of quality of life improvment after cholecystectomy according to ROME IV criteria [6 months]

    abdominal pain, nausea and vomiting

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 80 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Yassien Abd-Elkariem, General surgery resident, Assiut University
ClinicalTrials.gov Identifier:
NCT05587933
Other Study ID Numbers:
  • GB EF biliary colic normal US
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2022