Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients

Study Overview
=================
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.

Official Title
-----------------
Effect of Gastrectomy and Anastomosis on Chronic Metabolic Disease Such as Diabetes and Hypertension in Early Gastric Cancer Patients

Conditions
-----------------
Early Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: gastrectomy
* Procedure: Endoscopic submucosal dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastrectomy<br>Patients who underwent gastrectomy for early gastric cancer | Procedure: gastrectomy<br>* subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy<br>|
| Endoscopic submucosal dissection<br>Patients who underwent endoscopic submucosal dissection for early gastric cancer | Procedure: Endoscopic submucosal dissection<br>* endoscopic submucosal dissection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who quit previous medication for diabetes because of improved disease | 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. | 5 year after operation | 
| Proportion of patients who quit previous medication for hypertension because of improved disease | Proportion of patients who quit previous medication for hypertension because of improved disease among the patients who diagnosed as early gastric cancer and hypertension | 5 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 according to anastomosis | difference of proportion of patients who quit previous medication for diabetes among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy | 5 year 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 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 according to anastomosis | difference of proportion of patients who quit previous medication for hypertension among patients who underwent gastroduodenostomy and loop gastrojejunostomy and Roux-Y gastrojejunostomy | 5 years after operation | 
| difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation | difference of serum levels of c-peptide, Ghrelin, GIP, GLP-1, glucagon, insulin between before and after operation in patients with diabetes | 1 years after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early gastric cancer, diabetes, hypertension