To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410535
• Other study ID #: DW_UDCA005_P401
• Status: Recruiting
• Phase: Phase 4
• Start date: September 15, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: June 2022
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: DoJoong Park
• Phone: 82-2-2072-1490
• Email: dojoongpark[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 465
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Gallstones
• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	DoJoong Park	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with gallstones formed	The proportion of subjects with gallstones formed after gastrectomy.	at 3 years
Primary	Proportion of subjects with gallstones formed	The proportion of subjects with gallstones formed after gastrectomy.	at 5 years
Primary	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
Primary	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
Primary	The duration of UDCA	The duration of UDCA	up to 5 years
Primary	The dose of UDCA	The dose of UDCA	up to 5 years
Primary	The recurrence rate of gastric cancer	The recurrence rate of gastric cancer	up to 5 years
Primary	The survival rate of gastric cancer	The survival rate of gastric cancer	up to 5 years