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Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

Sponsor
Kyungpook National University Chilgok Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05543863
Collaborator
(none)
20
Enrollment
1
Location
9.3
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of postoperative bleeding complications and thromboembolic events.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Platelet function testing

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Radial Distal Gastrectomy for Gastric Cancer on the Pharmacokinetics of Oral Antiplatelet Agents
Actual Study Start Date :
Aug 20, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
May 31, 2023

Outcome Measures

Primary Outcome Measures

  1. platelet function testing at 5 days [5 days]

    Difference in the platelet function testing results between before and 5 days after surgery.

Secondary Outcome Measures

  1. Platelet function testing at 3 months [3 months]

    Difference in the platelet function testing results between before and 3 months after surgery

  2. postoperative complications [3 months]

    ■ incidence of postoperative bleeding and thromboembolic events within 3 months after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients diagnosed with pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition.

  • Patients who are scheduled to undergo distal gastrectomy (access: either minimally invasive surgery or open surgery)

  • Patients taking aspirin and/or clopidogrel for primary or secondary prevention for cardiovascular disease or cerebrovascular disease before surgery.

  • age 18 - 90 years

  • A person who voluntarily agrees to participate in this study and signs the consent form.

Exclusion Criteria:

  • Patients with coagulation disorder or abnormal findings in coagulation test (low platelet count, prolonged PT/aPTT)

  • Patients taking other anticoagulants in combination

  • Patients with imparied liver or renal function that may affect drug metabolism.

Impaired liver function: liver cirrhosis Impaired renal function: CKD grade 3 or higher

  • Patients requiring adjuvant chemotherapy after surgery that may affect postoperative bone marrow function and hematopoietic function (those with gastric cancer of clinical stage II or more according to the AJCC 8th edition)

  • Patients participating in other clinical trials within 6 months

  • Vulnerable patients (pregnant women, those with cognitive impairment, etc)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dept. of Surgery, Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404

Sponsors and Collaborators

  • Kyungpook National University Chilgok Hospital

Investigators

  • Principal Investigator: Ji Yeon Park, MD, Dept. of Surgery, Kyungpook National Univ. Chilgok Hosptal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ji Yeon Park, Ji Yeon Park, Kyungpook National University Chilgok Hospital
ClinicalTrials.gov Identifier:
NCT05543863
Other Study ID Numbers:
  • KNUCH 2022-general-08
First Posted:
Sep 16, 2022
Last Update Posted:
Sep 16, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stomach Neoplasms
Cerebrovascular Disorders
Cardiovascular Diseases

Study Results

No Results Posted as of Sep 16, 2022