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

A

Assiut University

Status

Not yet enrolling

Conditions

CKD
Gall Bladder Dysfunction

Treatments

Diagnostic Test: abdominal ultrasonography.

Study type

Observational

Funder types

Other

Identifiers

NCT06437418
Gallbladder dysfunction in CKD

Details and patient eligibility

About

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.

Full description

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.

Enrollment

108 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

108 participants in 3 patient groups

Group I
Description:
Gallbladder dysfunction in pre-dialysis CKD patients.
Treatment:
Diagnostic Test: abdominal ultrasonography.
Group II
Description:
Gallbladder dysfunction in end stage CKD patients on dialysis.
Treatment:
Diagnostic Test: abdominal ultrasonography.
Control Group
Description:
Gallbladder dysfunction in normal renal function participants (control group).
Treatment:
Diagnostic Test: abdominal ultrasonography.

Trial contacts and locations

1

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Central trial contact

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

Data sourced from clinicaltrials.gov

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