Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic SteatosisMAFLD-Chole StNCT07284004
Fatty Liver in Long Standing Cholecystectomy
An observational study of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic Steatosis, run by Yasmeen Ahmed Farrag Ahmed.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic Steatosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -
Who cannot join
- Patients less than 18 years old.
- Body mass index (BMI) ≤ 25 kg/m2
- Patients with chronic renal failure.
- Patients with liver cirrhosis.
- Patients with acute liver dysfunction.
- Breast feeding and pregnancy.
- patients have done cholecystectomy less than 5 years ago.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Long-term cholecystectomy patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of metabolic dysfunction-associated fatty liver disease (MAFLD) in patients after long term follow up post cholecystectomy
Measured: 5 years post-cholecystectomy
Secondary outcomes (1)
Changes in serum level of ALT in post-cholecystectomy patients
Measured: Annually for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic SteatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yasmeen Ahmed Farrag Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmeen Ahmed Farrag Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284004
- Sponsor's protocol ID
- Soh-Med--25-11-6MS
- Acronym
- MAFLD-Chole St
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patiens
- ClinicalTrials.gov ID
- NCT07284004
- Acronym / sponsor ID
- MAFLD-Chole St / Soh-Med--25-11-6MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yasmeen Ahmed Farrag AhmedUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-term cholecystectomy patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (7 listed)
- Patients less than 18 years old.
- Body mass index (BMI) ≤ 25 kg/m2
- Patients with chronic renal failure.
- Patients with liver cirrhosis.
- Patients with acute liver dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Changes in serum level of ALT in post-cholecystectomy patients
Time frame: Annually for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)-Post-cholecystectomy Metabolic Changes -Hepatic Steatosis, run by Yasmeen Ahmed Farrag Ahmed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen Ahmed Farrag (201027291125, yasmeen_ahmed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.