NCT05410535

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

A Multi-center, Phase IV, Extension Study in PEGASUS-D Trial to Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Patients who continued UDCA 300mg medication	patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
OTHER	Patients who discontinued UDCA 300mg prescription	patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Timeline

• Start date: 2021-09-15
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2022-06-08
• Last updated: 2024-06-28

Locations

1 site across 1 country: South Korea