Gastric Cancer
Conditions
Brief 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)
Interventions
DRUGPatients who continued UDCA 300mg medication
patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
OTHERPatients who discontinued UDCA 300mg prescription
patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
patients who participated in PEGASUS-D clinical trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with gallstones formed | at 3 years | The proportion of subjects with gallstones formed after gastrectomy. |
| 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 duration of UDCA | up to 5 years | The duration of UDCA |
| The dose of UDCA | up to 5 years | The dose of UDCA |
| The recurrence rate of gastric cancer | up to 5 years | The recurrence rate of gastric cancer |
| The survival rate of gastric cancer | up to 5 years | The survival rate of gastric cancer |
Countries
South Korea
Outcome results
None listed