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

Completed

• Conditions: Early Gastric Cancer
• Interventions: Procedure: Endoscopic submucosal dissection; Procedure: gastrectomy

• Registration Number: NCT01643811
• Lead Sponsor: National Cancer Center, Korea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-11
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic submucosal dissection	Endoscopic submucosal dissection	Patients who underwent endoscopic submucosal dissection for early gastric cancer
Gastrectomy	gastrectomy	Patients who underwent gastrectomy for early gastric cancer

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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 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
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 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

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Kyeonggi-do, Korea, Republic of