NCT06385860

Brief Summary

Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 23, 2024

Last Update Submit

April 28, 2024

Conditions

ObesityDiabetesGallstonesBiliary Stasis

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • other bariatric procedures.
  • contraindications for bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityDiabetes MellitusGallstonesCholestasis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesCholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalBile Duct Diseases

Central Study Contacts

siqi Wang

CONTACT

8618810315722wsqi@pku.edu.cn

Hua Meng

CONTACT

8618611457779menghuade@zryhyy.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 26, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

April 1, 2025

Last Updated

April 30, 2024

Record last verified: 2024-04