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Optimal time for initiation of Helicobacter pylori eradication after Endoscopic resection of gastric neoplasm

Status Approved

  • First Submitted Date

    2018/08/14

  • Registered Date

    2018/08/17

  • Last Updated Date

    2018/08/14

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003099
    Unique Protocol ID DKUH 2017-10-011-002
    Public/Brief Title Time for Helicobacter pylori eradication
    Scientific Title Optimal time for initiation of Helicobacter pylori eradication after Endoscopic resection of gastric neoplasm
    Acronym TIME
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number DKUH 2017-10-011-002
    Approval Date 2018-04-18
    Institutional Review Board Name Dankook University Hospital Institutional Review Board
    Institutional Review Board Address 201, Manghyang-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do
    Institutional Review Board Telephone 041-550-7491
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Ki Bae Bang
    Title Assistant professor
    Telephone +82-41-550-7630
    Affiliation Dankook Univeristy Hospital
    Address 201, Manghyang-ro, Dongnam-gu, Cheonan, Korea.
    Contact Person for Public Queries
    Name Ki Bae Bang
    Title Assistant professor
    Telephone +82-41-550-7630
    Affiliation Dankook Univeristy Hospital
    Address Dankook University College of Medicine, 201, Manghyang-ro, Dongnam-gu, Cheonan, Korea.
    Contact Person for Updating Information
    Name Ki Bae Bang
    Title Assistant professor
    Telephone +82-41-550-7630
    Affiliation Dankook Univeristy Hospital
    Address 201, Manghyang-ro, Dongnam-gu, Cheonan, Korea.
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 7
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-08-27 Anticipated
    Target Number of Participant 180
    Primary Completion Date 2019-02-28 , Anticipated
    Study Completion Date 2019-03-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Dankook Univeristy Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-08-27 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Konyang University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-09-24 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Chungnam National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-09-24 ,
    Recruitment Status by Participating Study Site 4
    Name of Study The Catholic University of Korea, Daejeon St. Mary's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-09-24 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Chungbuk National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-09-24 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Soon Chun Hyang University Hospital Cheonan
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-09-24 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Eulji University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2018-09-24 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Dankook Univeristy Hospital
    Organization Type Medical Institute
    Project ID DKUH 2017-10-011-002
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Dankook Univeristy Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Helicobacter pylori (HP) infection is a most common cause of chronic gastritis and it is a risk factor of gastric ulcer, stomach cancer, and MALT lymphoma of the stomach. International guidelines recommend eradication of HP infection. In the recent meta-analysis, HP eradication resulted in reduced incidence of metachronous neoplasm in patients with gastric neoplasm after endoscopic resection. However, evidences about optimal time for eradication of HP infection is scarce. Several retrospective studies have been reported different HP eradication rate according to the ulcer healing stage. Early eradication of HP associated with higher eradication rate compared to late eradication group after endoscopic resection in recent studies. But, controversies exist in this issue. The aims of current study are to evaluate the eradication rates, adverse events and compliance for HP therapy between the early and late treatment groups.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    The presence of HP infection is evaluated with rapid urease test, histology, and urea breath test. The patients with HP infection are grouped by treatment time after endoscopic resection of gastric neoplasm. Eradication therapy is initiated ≤ 2 weeks after endoscopic resection in the early treatment group and ≥ 8 weeks in the late treatment group. Triple therapy with standard dose of PPI, 1000mg of amoxicillin, and 500mg of clarithromycin, all given twice daily, is used for eradication therapy for 10 days. Urea breath test is used for the evaluation of HP eradication.
    Number of Arms 2
    Arm 1

    Arm Label

    Early treamtment group

    Target Number of Participant

    90

    Arm Type

    Experimental

    Arm Description

    Twice daily doses of 10 day triple therapy with standard dose of PPI, 1000mg of amoxicillin, and 500mg of clarithromycin are applied to the early treatment group ≤ 2 weeks after endoscopic resection of gastric neoplasm.
    Arm 2

    Arm Label

    Late treatment group

    Target Number of Participant

    90

    Arm Type

    Active comparator

    Arm Description

    Twice daily doses of 10 day triple therapy with standard dose of PPI, 1000mg of amoxicillin, and 500mg of clarithromycin are applied to the early treatment group ≥ 8 weeks after endoscopic resection of gastric neoplasm.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C16.90)Malignant neoplasm of stomach, unspecified, early 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~79Year

    Description

    Inclusion criteria
    ① ≥19 years of age and <80 years
    ② Patients with gastric neoplasm 
    ③ Positive for Helicobacter pylori by rapid urease test, histology, or urea breath test. 
    ④ Informed consent prior to study
    Exclusion Criteria
    Exclusion criteria
    ① <19 years of age and ≥80 years 
    ② Have a history of gastric surgery
    ③ Have to take following medications during the study period: Non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, clopidogrel, anticoagulant, steroid. 
    ④ Be pregnant during study period
    ⑤ Have an abnormal liver enzymes (3 times higher than the normal range of AST or ALT) or have a history of liver cirrhosis.
    ⑥ Have a history of major psychotic disorder
    ⑦ Have a previous history of Helicobacter pylori eradication. 
    ⑧ Have a history of allergic drug reaction to antibiotics for Helicobacter pylori eradication
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Eradication rates of H.pylori infection
    Timepoint
    3 months after endoscopic resection
    Secondary Outcome(s) 1
    Outcome
    post-ESD bleeding
    Timepoint
    14 days after endoscopic resection
    Secondary Outcome(s) 2
    Outcome
    Adverse drug event and compliance
    Timepoint
    After 10 days H. pylori eradication therapy
    Secondary Outcome(s) 3
    Outcome
    Ulcer healing
    Timepoint
    3 months after endoscopic resection
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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