Status:
COMPLETED
Role of Statin on the Gastric Inflammation in Patients at High Risk of Gastric Cancer
Lead Sponsor:
Yonsei University
Conditions:
Early Gastric Cancer or Gastric Adenoma
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
Statins are commonly used as cholesterol-lowering medications and have shown effectiveness in the primary and secondary prevention of heart attack and stroke. In addition, several recent studies of hu...
Eligibility Criteria
Inclusion
- Age, between 20 and 70
- Early gastric cancer or adenoma which is achieved curative resection by endoscopic submucosal dissection
- ECOG performance status 0 or 1
Exclusion
- Previous subtotal gastrectomy or gastrostomy
- Repeated endoscopic submucosal dissection
- Two or more synchronous lesions
- Presence of gastric or duodenal ulcer except artificial ulcer due to endoscopic submucosal dissection
- 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
- Indication of statins, including dyslipidemia, myocardial infarction, and heart failure.
- Develop of complications caused by endoscopic submucosal dissection, including bleeding, perforation, and pneumonia
- LDL \< 70 mg/dL
- Allergy to statins
- Pregnancy or breast milk feeding
- Active infection
- Significant cardiopulmonary disease
- Active hepatitis or severe hepatic dysfunction
- Severe renal dysfunction
- Severe bone marrow dysfunction
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2018
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01813994
Start Date
November 1 2014
End Date
June 19 2018
Last Update
March 29 2019
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 120-752