ClinicalTrials.gg
Not yet recruitingNCT06385860PM-EBS-BSUpdated Apr 30, 2024

Prediction Model for Early Biliary Stasis After Bariatric Surgery

An observational study in Obesity, Diabetes and Gallstones, sponsored by China-Japan Friendship Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by China-Japan Friendship Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
200
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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)

02

Conditions studied

  • Obesity
  • Diabetes
  • Gallstones
  • Biliary Stasis
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 200 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 178 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. ≥32.5 kg/m2 with one or more obesity-related comorbidities.
  2. BMI >35 kg/m2 without coexisting medical problems
  3. complete preoperative and follow-up data.

Exclusion criteria

Exclusion Criteria:

  1. other bariatric procedures.
  2. for bariatric surgery.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. early biliary stasis

    The incidence of early biliary stasis after bariatric surgery

    Time frame: one month

  2. prediction model

    Area under the curve (AUC) of the prediction model

    Time frame: six months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Sep 2024, 2 months later.

Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 2 months is below that.

Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2024
First posted
Apr 26, 2024
StartEst.
Jul 2024
Primary completionEst.
Sep 2024
CompletionEst.
Apr 2025
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06385860
Responsible party
Wang Siqi (Principal Investigator, China-Japan Friendship Hospital) — Principal investigator
First posted
Apr 26, 2024
Start date
Jul 2024 (estimated)
Primary completion
Sep 2024 (estimated)
Completion
Apr 2025 (estimated)
Last update
Apr 30, 2024

Study contacts

siqi Wang
Contact
wsqi@pku.edu.cn
8618810315722
Hua Meng
Contact
menghuade@zryhyy.com.cn
8618611457779

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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