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Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors

NCT ID: NCT06437418

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-07-31

Brief Summary

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Our aim in this cross-sectional study is to determine the frequency and aspects of gallbladder dysfunction and the related risk factors in pre-ESRD and hemodialysis patients.

Detailed Description

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Biliary tract disorders including cholelithiasis, cholecystitis, and other diseases of the biliary tract, are one of the most prevalent medical issues in the digestive system, posing a myriad of challenges for health workers and patients. Gallbladder dysfunction is the most frequent cause of symptomatic and complicated biliary tract disorders. Although gallbladder dysfunction is a common condition in Middle East countries, data on the incidence of end-stage renal disease (ESRD) are limited. The occurrence of gallbladder dysfunction in patients fed with low-protein diets suggests that gallbladder stones formation is affected by dietary protein content. Also the lithogenic composition changes of bile, increased nucleation tendency, and impaired motility of gallbladder are important factors in ESRD patients. It has been reported that chronic kidney disease (CKD) patients on regular hemodialysis (HD) have increased bile cholesterol levels and an increased bile saturation index. In addition, the gallbladder is innervated by the autonomic nervous system, which malfunctions in uremia, and it has been shown that gallbladder stasis might cause increased stone formation. In some studies, the prevalence of gallbladder dysfunction has been shown to increase in patients undergoing hemodialysis (HD) treatment for ESRD. So, we focused in this study to try to find association of gallbladder dysfunction in pre-dialysis ESRD and HD patient in comparison to normal renal function individuals.

Conditions

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CKD Gall Bladder Dysfunction

Keywords

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CKD gall bladder dysfunction gall bladder ejection fraction hemodialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group I

Gallbladder dysfunction in pre-dialysis CKD patients.

abdominal ultrasonography.

Intervention Type DIAGNOSTIC_TEST

Evaluate the gallbladder ejection fraction (EF)

Group II

Gallbladder dysfunction in end stage CKD patients on dialysis.

abdominal ultrasonography.

Intervention Type DIAGNOSTIC_TEST

Evaluate the gallbladder ejection fraction (EF)

Control Group

Gallbladder dysfunction in normal renal function participants (control group).

abdominal ultrasonography.

Intervention Type DIAGNOSTIC_TEST

Evaluate the gallbladder ejection fraction (EF)

Interventions

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abdominal ultrasonography.

Evaluate the gallbladder ejection fraction (EF)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients who are diagnosed as CKD with eGFR according to Cockcroft-Gault Equation, whatever they are on regular hemodialysis or pre-dialysis without history of previous gallbladder dysfunction with normal renal function individuals.

Exclusion Criteria

* Patients who are younger than 18 years.
* Patients who are diabetic.
* Patients who have body mass index (BMI) more than 30.
* Patients who have family history of gallbladder disorder.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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rehab Mohamed Mohamed

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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faculty of medicine Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Rehab Mohamed Mohamed Eltayeb, M.B.B.CH.

Role: CONTACT

Phone: 01016644593

Email: [email protected]

Facility Contacts

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Rehab Mohamed Mohamed Eltayeb Ahmed, M.B.B.CH.

Role: primary

Other Identifiers

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Gallbladder dysfunction in CKD

Identifier Type: -

Identifier Source: org_study_id