To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
-
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients who received UDCA 600mg Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg |
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
|
| Experimental: Patients who received UDCA 300mg Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg |
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
|
| Placebo Comparator: Patients who received Placebo Patients who participated in PEGASUS-D clinical trial and received Placebo |
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
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with gallstones formed [at 3 years]
The proportion of subjects with gallstones formed after gastrectomy.
- Proportion of subjects with gallstones formed [at 5 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 incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy. [at 5 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | DoJoong Park | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
- Principal Investigator: DoJoong Park, Seoul National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_UDCA005_P401