Prediction Model for Early Biliary Stasis After Bariatric... | NCT06385860

Studies
Prediction Model for Early Biliary Stasis After Bariatric Surgery

NCT06385860

Sponsor

China-Japan Friendship Hospital

Status

Unknown status

Last Update Posted

Apr 30, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Obesity
Diabetes
Gallstones
Biliary Stasis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2024Estimated

Primary Completion Date

Sep 2024Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Apr 23, 2024

First Submission Date that Met QC Criteria

Apr 23, 2024

First Posted Date

Apr 26, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2024

Last Update Posted Date

Apr 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wang Siqi, Principal Investigator, China-Japan Friendship HospitalPrincipal Investigator

Lead Sponsor

China-Japan Friendship HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
early biliary stasis	The incidence of early biliary stasis after bariatric surgery	one month
prediction model	Area under the curve (AUC) of the prediction model	six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

other bariatric procedures.
contraindications for bariatric surgery.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

This study aims to include patients who will undergo bariatric surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
siqi Wang	Contact	8618810315722		wsqi@pku.edu.cn
Hua Meng	Contact	8618611457779		menghuade@zryhyy.com.cn

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D003920	Diabetes Mellitus
D042882	Gallstones
D002779	Cholestasis

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided