MAFLDNCT07297225
Metabolic Dysfunction-Associated Fatty Liver Disease Impairs Intraoperative Indocyanine Green Fluorescence Cholangiography Quality: Development and Validation of a Predictive Model
An observational study of MAFLD and Cholecystitis, run by Zhujiang Hospital at 1 site in China.
Trial summary
Near-infrared fluorescence cholangiography has been shown to improve the clinical outcomes of laparoscopic cholecystectomy (LC). However, it remains unclear whether hepatic steatosis in patients with metabolic dysfunction-associated fatty liver disease (MAFLD) influences the quality of indocyanine green fluorescence… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MAFLD, Cholecystitis, Gallbladder Polyps
- What is being tested?
- Retrospective observational study without intervention measures
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2025to 20 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (1) Age 18-75 years, any sex; (2) Definite surgical indication for cholecystectomy; (3) Underwent LC; (4) No severe contraindications such as significant cardiac, pulmonary, renal, or cerebral dysfunction.
Who may be able to join
- Age 18-75 years, any sex;
- Definite surgical indication for cholecystectomy;
- Underwent LC;
- No severe contraindications such as significant cardiac, pulmonary, renal, or cerebral dysfunction.
Who cannot join
- Known allergy to ICG or iodinated contrast agents;
- Use of medications affecting biliary excretion within 2 weeks prior to surgery; (3) LC without ICG-FI;
- Incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
About this study
Near-infrared fluorescence cholangiography has been shown to improve the clinical outcomes of laparoscopic cholecystectomy (LC). However, it remains unclear whether hepatic steatosis in patients with metabolic dysfunction-associated fatty liver disease (MAFLD) influences the quality of indocyanine green fluorescence imaging (ICG-FI), and whether the quality can be predicted preoperatively. This study aimed to evaluate the impact of MAFLD on intraoperative fluorescence quality and to develop a multiple linear regression model for predicting intraoperative ICG-FI.
- Conditions
- MAFLD, Cholecystitis, Gallbladder Polyps, Cholelithiasis
- Being tested
- Retrospective observational study without intervention measures
- Medical subject headings
- Cholecystitis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective observational study without intervention measuresOther
Retrospective observational study without intervention measures
| Study group | Role | What they receive |
|---|---|---|
| Non-MAFLD Group | Not described Receives: Other: Retrospective observational study without intervention measures | |
| MAFLD Group | Not described Receives: Other: Retrospective observational study without intervention measures | |
| Training Cohort | Not described Receives: Other: Retrospective observational study without intervention measures | |
| Validation Cohort | Not described Receives: Other: Retrospective observational study without intervention measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common bile duct FI / Liver background FI (C/L)
The common bile duct-to-liver background fluorescence intensity ratio (C/L) [Unit: Dimensionless number] [Time Frame: Perioperative period] [Measurement steps: Three photographs per case were obtained with the following requirements: Calot's triangle centred in the image, liver background positioned superiorly, and the CBD inferiorly, ensuring all measurement sites were visible and unobstructed. Each image was converted to greyscale, and regions of interest (ROI) of >3000 pixels were selected for each critical structure to calculate FI. The mean FI from the three images was recorded as the final value for each structure.]
Measured: Perioperative period
Secondary outcomes (1)
Qualitative assessment of fluorescence visualization
Qualitative assessment of fluorescence visualization. [Time Frame: Perioperative period] [Unit: Dimensionless number] [Measurement steps: It was performed by three senior surgeonsScores were averaged and graded on a five-point scale adapted from previous studies (1=completely invisible, impairs visualization; 2=poor, faint fluorescence, no added value; 3= visible but blurred, some added value; 4=good, clear visualization with significant added value; 5= excellent, very clear visualization with typical added value)]
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start31 Jan 2025
- Primary completion30 May 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MAFLDStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297225
- Sponsor's protocol ID
- 2025-KY-323
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Dysfunction-Associated Fatty Liver Disease Impairs Intraoperative Indocyanine Green Fluorescence Cholangiography Quality: Development and Validation of a Predictive Model
- ClinicalTrials.gov ID
- NCT07297225
- Acronym / sponsor ID
- 2025-KY-323
- Conditions
- MAFLD, Cholecystitis, Gallbladder Polyps, Cholelithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 22 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.
Near-infrared fluorescence cholangiography has been shown to improve the clinical outcomes of laparoscopic cholecystectomy (LC). However, it remains unclear whether hepatic steatosis in patients with metabolic dysfunction-associated fatty liver disease (MAFLD) influences the quality of indocyanine green fluorescence imaging (ICG-FI), and whether the quality can be predicted preoperatively. This study aimed to evaluate the impact of MAFLD on intraoperative fluorescence quality and to develop a multiple linear regression model for predicting intraoperative ICG-FI.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-MAFLD Group | – | Other: Retrospective observational study without intervention measures |
| MAFLD Group | – | Other: Retrospective observational study without intervention measures |
| Training Cohort | – | Other: Retrospective observational study without intervention measures |
| Validation Cohort | – | Other: Retrospective observational study without intervention measures |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) Age 18-75 years, any sex; (2) Definite surgical indication for cholecystectomy; (3) Underwent LC; (4) No severe contraindications such as significant cardiac, pulmonary, renal, or cerebral dysfunction.
Key inclusion criteria (4 listed)
- Age 18-75 years, any sex;
- Definite surgical indication for cholecystectomy;
- Underwent LC;
- No severe contraindications such as significant cardiac, pulmonary, renal, or cerebral dysfunction.
Key exclusion criteria (3 listed)
- Known allergy to ICG or iodinated contrast agents;
- Use of medications affecting biliary excretion within 2 weeks prior to surgery; (3) LC without ICG-FI;
- Incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective observational study without intervention measuresRetrospective observational study without intervention measures | Other | MAFLD Group, Non-MAFLD Group, Training Cohort, Validation Cohort |
Primary outcome
Common bile duct FI / Liver background FI (C/L)
Time frame: Perioperative period
The common bile duct-to-liver background fluorescence intensity ratio (C/L) [Unit: Dimensionless number] [Time Frame: Perioperative period] [Measurement steps: Three photographs per case were obtained with the following requirements: Calot's triangle centred in the image, liver background positioned superiorly, and the CBD inferiorly, ensuring all measurement sites were visible and unobstructed. Each image was converted to greyscale, and regions of interest (ROI) of >3000 pixels were selected for each critical structure to calculate FI. The mean FI from the three images was recorded as the final value for each structure.]
1 secondary outcome
Qualitative assessment of fluorescence visualization
Time frame: Perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MAFLD and Cholecystitis, run by Zhujiang Hospital at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common bile duct FI / Liver background FI (C/L) (time frame: Perioperative period). 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 22 Dec 2025.