Fatty Liver in Long Standing Cholecystectomy (MAFLD-Chole St)

December 14, 2025 updated by: Yasmeen Ahmed Farrag Ahmed

Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patiens

This observational study aims to evaluate the association between long-term cholecystectomy and the development of metabolic dysfunction-associated fatty liver disease (MAFLD) in adult patients. The study will assess the prevalence and severity of hepatic steatosis in individuals who underwent cholecystectomy several years earlier and compare clinical, metabolic, and biochemical parameters to identify potential risk factors. The goal is to determine whether cholecystectomy contributes to metabolic alterations that increase the likelihood of MAFLD in the long term.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥18 years) who have undergone cholecystectomy at least 5 years prior to enrollment, with no known chronic liver diseases other than metabolic dysfunction-associated fatty liver disease (MAFLD). Participants will be recruited from outpatient gastroenterology clinics and will provide informed consent before enrollment. Both male and female patients will be included.

Description

Inclusion Criteria:

-

Exclusion Criteria:

  1. Patients less than 18 years old.
  2. Body mass index (BMI) ≤ 25 kg/m2
  3. Patients with chronic renal failure.
  4. Patients with liver cirrhosis.
  5. Patients with acute liver dysfunction.
  6. Breast feeding and pregnancy.
  7. patients have done cholecystectomy less than 5 years ago.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Long-term cholecystectomy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of metabolic dysfunction-associated fatty liver disease (MAFLD) in patients after long term follow up post cholecystectomy
Time Frame: 5 years post-cholecystectomy
5 years post-cholecystectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in serum level of ALT in post-cholecystectomy patients
Time Frame: Annually for 5 years
Annually for 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yasmeen Ahmed Farrag Ahmed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Soh-Med--25-11-6MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic Steatosis

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