Early Gastric Cancer
Conditions
Keywords
early gastric cancer, diabetes, hypertension
Brief summary
The purpose of this study is to determine whether the extent of gastrectomy and anastomosis type affect chronic metabolic disease such as diabetes and hypertension in early gastric cancer patients.
Interventions
PROCEDUREgastrectomy
subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy
PROCEDUREEndoscopic submucosal dissection
endoscopic submucosal dissection
Sponsors
National Cancer Center, Korea
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who quit previous medication for diabetes because of improved disease | 5 year after operation | 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. |
| Proportion of patients who quit previous medication for hypertension because of improved disease | 5 years after operation | Proportion of patients who quit previous medication for hypertension because of improved disease among the patients who diagnosed as early gastric cancer and hypertension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy | 5 years after operation | difference of proportion of patients who quit previous medication for hypertension between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy |
| difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy | 5 years after operation | difference of proportion of patients who quit previous medication for diabetes between patients who underwent subtotal gastrectomy and those who underwent total gastrectomy |
| difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation | 1 years after operation | difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation in patients with diabetes |
| difference of proportion of patients who quit previous medication for hypertension according to anastomosis | 5 years after operation | difference of proportion of patients who quit previous medication for hypertension among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy |
| difference of proportion of patients who quit previous medication for diabetes according to anastomosis | 5 year after operation | difference of proportion of patients who quit previous medication for diabetes among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy |
Countries
South Korea
Outcome results
None listed