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Clinical Trials/NCT05587933
NCT05587933Not yet recruitingNot Applicable

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

Assiut University0 sites20 target enrollmentStarted: October 25, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
20
Primary Endpoint
Rate of quality of life improvment after cholecystectomy according to ROME IV criteria

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
12 Years to 80 Years (Child, Adult, Older Adult)
Sex
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

Arms & Interventions

operative

Experimental

Intervention: cholecystectomy (Procedure)

operative

Experimental

Intervention: Antispasmodic (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 6 months

abdominal pain, nausea and vomiting

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Yassien Abd-Elkariem

General surgery resident

Assiut University

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