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

NCT ID: NCT05587933

Last Updated: 2022-10-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2023-07-01

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.

Conditions

Gall Bladder Pain; Hepatobiliary Iminodiacetic Acid; Acalculous Cholecystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

operative

Group Type: EXPERIMENTAL

cholecystectomy

Intervention Type: PROCEDURE

cholecystectomy

Antispasmodic

Intervention Type: DRUG

Antispasmodic

Interventions

cholecystectomy

cholecystectomy

Intervention Type: PROCEDURE

Antispasmodic

Antispasmodic

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Yassien Abd-Elkariem

General surgery resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

GB EF biliary colic normal US

Identifier Type: -

Identifier Source: org_study_id