ObesityPM-EBS-BSNCT06385860
Prediction Model for Early Biliary Stasis After Bariatric Surgery
An observational study of Obesity and Diabetes, run by China-Japan Friendship Hospital.
Trial summary
Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Diabetes, Gallstones
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study aims to include patients who will undergo bariatric surgery.
Who may be able to join
- BMI ≥32.5 kg/m2 with one or more obesity-related comorbidities.
- BMI >35 kg/m2 without coexisting medical problems
- complete preoperative and follow-up data.
Who cannot join
- other bariatric procedures.
- contraindications for bariatric surgery.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on the Prediction Model for Early Biliary Stasis After Bariatric Surgery Based on Machine Learning Algorithms
Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery
Read the detailed description
This study aims to create and validate a model that predicts the likelihood of early biliary stasis in obese patients following bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass)
- Conditions
- Obesity, Diabetes, Gallstones, Biliary Stasis
- Medical subject headings
- Obesity, Diabetes Mellitus, Gallstones, Cholestasis
What is being measured
The primary outcome is the main question the study is designed to answer.
early biliary stasis
The incidence of early biliary stasis after bariatric surgery
Measured: one month
prediction model
Area under the curve (AUC) of the prediction model
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study startJul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Siqi, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385860
- Sponsor's protocol ID
- GTMGS0423
- Acronym
- PM-EBS-BS
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Prediction Model for Early Biliary Stasis After Bariatric Surgery Based on Machine Learning Algorithms
- ClinicalTrials.gov ID
- NCT06385860
- Acronym / sponsor ID
- PM-EBS-BS / GTMGS0423
- Conditions
- Obesity, Diabetes, Gallstones, Biliary Stasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 26 Apr 2024 (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.
Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery
Detailed description
This study aims to create and validate a model that predicts the likelihood of early biliary stasis in obese patients following bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass)
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study aims to include patients who will undergo bariatric surgery.
Key inclusion criteria (3 listed)
- BMI ≥32.5 kg/m2 with one or more obesity-related comorbidities.
- BMI >35 kg/m2 without coexisting medical problems
- complete preoperative and follow-up data.
Key exclusion criteria (2 listed)
- other bariatric procedures.
- contraindications for bariatric surgery.
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
early biliary stasis
Time frame: one month
The incidence of early biliary stasis after bariatric surgery
prediction model
Time frame: six months
Area under the curve (AUC) of the prediction model
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by China-Japan Friendship Hospital.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact siqi Wang (8618810315722, wsqi@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early biliary stasis (time frame: one month). The study lists 2 primary outcomes in all. 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 30 Apr 2024.