To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2022-10-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.

The medical records of the patients will be reviewed throughout the study.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer

NCT02490111

Gastric Cancer

COMPLETED PHASE3

UDCA for Symptomatic Gallstone Disease

NCT00161083

Cholecystolithiasis

COMPLETED PHASE4

The Effect in Wedge Resection and IVb/V Resection of the Liver for Gallbladder Cancer

NCT02920554

Gallbladder Cancer

RECRUITING NA

If Chronic Gallbladder Diseases Increase the Incidence of PEC

NCT04242394

Cholecystitis

COMPLETED

The Incidence of Gallstones After Gastrectomy

NCT05965466

Gallstone Gastric Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.

* Collection of retrospective cohort data

1)The medical records from the subject's gastrectomy surgery date to Visit1 will be collected through a questionnaire and by reviewing the medical records of the patient.
* Collection of prospective cohort data

1. Based on visit 1, if the subjects whose date of gastrectomy surgery date is more than 3 years(36 months) and less than 5 years(60 months), the subject should visit the institution at the time of 5 years(60 months, visit2) after gastrectomy surgery to evaluate data requested at visit2.
2. The medical records will be accessed and collected from the subject's gastrectomy surgery date up to 5 years(60 months)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

patients who participated in PEGASUS-D clinical trial

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients who received UDCA 600mg

Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg

Group Type EXPERIMENTAL

Patients who discontinued UDCA 300mg prescription

Intervention Type OTHER

patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who continued UDCA 300mg medication

Intervention Type DRUG

patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who received UDCA 300mg

Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg

Group Type EXPERIMENTAL

Patients who discontinued UDCA 300mg prescription

Intervention Type OTHER

patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who continued UDCA 300mg medication

Intervention Type DRUG

patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who received Placebo

Patients who participated in PEGASUS-D clinical trial and received Placebo

Group Type PLACEBO_COMPARATOR

Patients who discontinued UDCA 300mg prescription

Intervention Type OTHER

patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who continued UDCA 300mg medication

Intervention Type DRUG

patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Patients who discontinued UDCA 300mg prescription

patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Intervention Type OTHER

Patients who continued UDCA 300mg medication

patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Among the PEGASUS-D Full Analysis Set (FAS) subjects, those who agree to participate in this clinical trial or those who can collect retrospective cohort data after waiving consent according to the consent waiver criteria