Clinical trial NCT05410535: To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastric Cancer
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 431
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: patients who participated in PEGASUS-D clinical trial
Primary purpose: OTHER

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects with gallstones formed
timeFrame: at 3 years
measure: Proportion of subjects with gallstones formed
timeFrame: at 5 years
measure: The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
timeFrame: at 3 years
measure: The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
timeFrame: at 5 years
measure: The duration of UDCA
timeFrame: up to 5 years
measure: The dose of UDCA
timeFrame: up to 5 years
measure: The recurrence rate of gastric cancer
timeFrame: up to 5 years
measure: The survival rate of gastric cancer
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: DoJoong Park
Study officials:
affiliation: Seoul National University Hospital
name: DoJoong Park
role: PRINCIPAL_INVESTIGATOR
References: