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
CRIS Registration Number |
KCT0003099 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 7 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Dankook Univeristy Hospital |
Organization Type | Medical Institute |
Project ID | DKUH 2017-10-011-002 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Dankook Univeristy Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C16.90)Malignant neoplasm of stomach, unspecified, early |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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