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

Primary Purpose

Gall Bladder Pain, Hepatobiliary Iminodiacetic Acid, Acalculous Cholecystitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

cholecystectomy

Antispasmodic

Sponsored by

Assiut University

About this trial

This is an interventional diagnostic trial for Gall Bladder Pain

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

operative

Arm Description

Outcomes

Primary Outcome Measures

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

abdominal pain, nausea and vomiting

Secondary Outcome Measures

Full Information

NCT ID

First Posted

September 24, 2022

Last Updated

October 18, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05587933

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 25, 2022 (Anticipated)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gall Bladder Pain, Hepatobiliary Iminodiacetic Acid, Acalculous Cholecystitis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

operative

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

cholecystectomy

Intervention Description

cholecystectomy

Intervention Type

Drug

Intervention Name(s)

Antispasmodic

Intervention Description

Antispasmodic

Primary Outcome Measure Information:

Title

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

Description

abdominal pain, nausea and vomiting

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Learn more about this trial

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

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