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Completed

NCT Number: NCT05410535

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DoJoong Park

Seoul, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patients who continued UDCA 300mg medication

Drug

patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who discontinued UDCA 300mg prescription

Other

patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Primary outcomes

  1. Proportion of subjects with gallstones formed

    Time frame: at 3 years

    The proportion of subjects with gallstones formed after gastrectomy.

  2. Proportion of subjects with gallstones formed

    Time frame: at 5 years

    The proportion of subjects with gallstones formed after gastrectomy.

  3. The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.

    Time frame: at 3 years

    The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.

  4. The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.

    Time frame: at 5 years

    The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.

  5. The duration of UDCA

    Time frame: up to 5 years

    The duration of UDCA

  6. The dose of UDCA

    Time frame: up to 5 years

    The dose of UDCA

  7. The recurrence rate of gastric cancer

    Time frame: up to 5 years

    The recurrence rate of gastric cancer

  8. The survival rate of gastric cancer

    Time frame: up to 5 years

    The survival rate of gastric cancer

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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