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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06437418
Enrollment
108
Registered
2024-05-31
Start date
2024-06-30
Completion date
2025-07-31
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD, Gall Bladder Dysfunction

Keywords

CKD, gall bladder dysfunction, gall bladder ejection fraction, hemodialysis

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTabdominal ultrasonography.

Evaluate the gallbladder ejection fraction (EF)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Gallbladder dysfunction in CKD patientsmeasuring fasting gallbladder volume (FV) after 10 overnight hours fasting and the residual gallbladder volume (RV) after 30 minutes after standard fixed mealEvaluate the gallbladder ejection fraction (EF) which will be calculated by following formula. (EF = (fasting gallbladder volume (FV) - residual gallbladder volume (RV)) / fasting gallbladder volume (FV)x 100) EF = (FV - RV) / FV x 100

Countries

Egypt

Contacts

Primary ContactRehab Mohamed Mohamed Eltayeb, M.B.B.CH.
rehab.eltaib@med.aun.edu.eg01016644593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026