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N/A
20 Years
70 Years
Not Enrolling
Both
Early Gastric Cancer or Gastric Adenoma

Thank you

Trial Information


Inclusion Criteria:



1. Age, between 20 and 70

2. Early gastric cancer or adenoma which is achieved curative resection by endoscopic
submucosal dissection

3. ECOG performance status 0 or 1

Exclusion Criteria:

1. Previous subtotal gastrectomy or gastrostomy

2. Repeated endoscopic submucosal dissection

3. Two or more synchronous lesions

4. Presence of gastric or duodenal ulcer except artificial ulcer due to endoscopic
submucosal dissection

5. History of drugs which are able to induce gastric ulcer including aspirin, NSAIDs,
and steroid (30 days or more, within 1 year at the time of screening

6. Indication of statins, including dyslipidemia, myocardial infarction, and heart
failure.

7. Develop of complications caused by endoscopic submucosal dissection, including
bleeding, perforation, and pneumonia

8. LDL < 70 mg/dL

9. Allergy to statins

10. Pregnancy or breast milk feeding

11. Active infection

12. Significant cardiopulmonary disease

13. Active hepatitis or severe hepatic dysfunction

14. Severe renal dysfunction

15. Severe bone marrow dysfunction

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Chronic inflammation score

Outcome Description:

Chronic inflmmation score will be assesed by histology accroding to the Sydney system.

Outcome Time Frame:

6 months from the start of taking the statins

Safety Issue:

Yes

Authority:

Korea: Institutional Review Board

Study ID:

4-2012-0889

NCT ID:

NCT01813994

Start Date:

April 2013

Completion Date:

July 2014

Related Keywords:

  • Early Gastric Cancer or Gastric Adenoma
  • Statin; Gastric inflammation; Gastric cancer
  • Adenoma
  • Gastritis
  • Inflammation
  • Stomach Neoplasms

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