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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 431
- 试验地点
- 1
- 主要终点
- Proportion of subjects with gallstones formed
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •A person who, at the discretion of the investigator, is deemed difficult to participate in this clinical trial.
研究组 & 干预措施
Patients who received UDCA 600mg
Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg
干预措施: Patients who continued UDCA 300mg medication (Drug)
Patients who received UDCA 600mg
Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg
干预措施: Patients who discontinued UDCA 300mg prescription (Other)
Patients who received UDCA 300mg
Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg
干预措施: Patients who continued UDCA 300mg medication (Drug)
Patients who received UDCA 300mg
Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg
干预措施: Patients who discontinued UDCA 300mg prescription (Other)
Patients who received Placebo
Patients who participated in PEGASUS-D clinical trial and received Placebo
干预措施: Patients who continued UDCA 300mg medication (Drug)
Patients who received Placebo
Patients who participated in PEGASUS-D clinical trial and received Placebo
干预措施: Patients who discontinued UDCA 300mg prescription (Other)
结局指标
主要结局
Proportion of subjects with gallstones formed
时间窗: 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.
时间窗: at 5 years
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
The duration of UDCA
时间窗: up to 5 years
The duration of UDCA
The dose of UDCA
时间窗: up to 5 years
The dose of UDCA
The recurrence rate of gastric cancer
时间窗: up to 5 years
The recurrence rate of gastric cancer
The survival rate of gastric cancer
时间窗: up to 5 years
The survival rate of gastric cancer
次要结局
未报告次要终点