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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received UDCA 600mg | Experimental | Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg |
|
| Patients who received UDCA 300mg | Experimental | Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg |
|
| Patients who received Placebo | Placebo Comparator | Patients who participated in PEGASUS-D clinical trial and received Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients who continued UDCA 300mg medication | Drug | patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial |
|
| 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 |
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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
Exclusion Criteria:
A person who, at the discretion of the investigator, is deemed difficult to participate in this clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| DoJoong Park | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DoJoong Park | Seoul | South Korea |
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patients who participated in PEGASUS-D clinical trial
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| Patients who discontinued UDCA 300mg prescription | Other | patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial |
|
The survival rate of gastric cancer |
| up to 5 years |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D055656 | Prescriptions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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