Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
N/A
20 Years
80 Years
20 Years
80 Years
Open (Enrolling)
Both
Early Gastric Cancer
Both
Early Gastric Cancer
Trial Information
Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients
Inclusion Criteria:
- Histologically proven primary gastric adenocarcinoma
- clinical stage Ia or Ib examined with endoscopy, endoscopic ultrasound, and computed
tomography
- aged 20-80 year old,
- performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- diagnosed as diabetes or hypertension
- patients planning to undergo gastrectomy or endoscopic submucosal dissection
- written informed consent
Exclusion Criteria:
- having high risk for operation such as severe heart disease, severe respiratory
disease
- pregnant
- previous abdominal surgery or radiation therapy
- proven more advanced disease than pathological stage II requiring adjuvant
chemotherapy
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Proportion of patients who quit previous medication for diabetes because of improved disease
Outcome Description:
proportion of patients who quit their previous medication for diabetes because of improved disease after operation among all patients who underwent gastrectomy for early gastric cancer with diabetes.
Outcome Time Frame:
5 year after operation
Safety Issue:
No
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
1210552-1
NCT ID:
NCT01643811
Start Date:
April 2012
Completion Date:
December 2014
Related Keywords:
- Early Gastric Cancer
- early gastric cancer, diabetes, hypertension
- Hypertension
- Stomach Neoplasms
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