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

Study Overview
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Brief Summary
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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
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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 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. The medical records will be accessed and collected from the subject's gastrectomy surgery date up to 5 years(60 months)

Official Title
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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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: Patients who continued UDCA 300mg medication
* Other: Patients who discontinued UDCA 300mg prescription


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient who participated in PEGASUS-D Clinical trial, and is willing to participate in this study by signing the informed consent form. Or the patient whose medical records can be accessed according to site's consent exemption criteria. Exclusion Criteria: The patient who the investigator finds it difficult to participate in this clinical trial.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: patients who participated in PEGASUS-D clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who received UDCA 600mg<br>Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg | Drug: Patients who continued UDCA 300mg medication<br>* patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial<br>Other: Patients who discontinued UDCA 300mg prescription<br>* patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial<br>|
| Experimental: Patients who received UDCA 300mg<br>Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg | Drug: Patients who continued UDCA 300mg medication<br>* patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial<br>Other: Patients who discontinued UDCA 300mg prescription<br>* patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial<br>|
| Placebo Comparator: Patients who received Placebo<br>Patients who participated in PEGASUS-D clinical trial and received Placebo | Drug: Patients who continued UDCA 300mg medication<br>* patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial<br>Other: Patients who discontinued UDCA 300mg prescription<br>* patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with gallstones formed | The proportion of subjects with gallstones formed after gastrectomy. | at 3 years | 
| Proportion of subjects with gallstones formed | The proportion of subjects with gallstones formed after gastrectomy. | at 5 years | 
| The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy. | The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy. | at 3 years | 
| The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy. | The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy. | at 5 years | 
| The duration of UDCA | The duration of UDCA | up to 5 years | 
| The dose of UDCA | The dose of UDCA | up to 5 years | 
| The recurrence rate of gastric cancer | The recurrence rate of gastric cancer | up to 5 years | 
| The survival rate of gastric cancer | The survival rate of gastric cancer | up to 5 years |