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

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

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.

Study Overview

• Status: Completed
• Conditions: Early Gastric Cancer
• Intervention / Treatment: Procedure: gastrectomy; Procedure: Endoscopic submucosal dissection

• Study Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyeonggi-do
    • Goyang, Kyeonggi-do, Korea, Republic of, 410-769
      • National Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients diagnosed as early gastric cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastrectomy; Patients who underwent gastrectomy for early gastric cancer	Procedure: gastrectomy; subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy
Endoscopic submucosal dissection; Patients who underwent endoscopic submucosal dissection for early gastric cancer	Procedure: Endoscopic submucosal dissection; endoscopic submucosal dissection

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

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Estimate): March 24, 2016
• Last Update Submitted That Met QC Criteria: March 23, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: early gastric cancer, diabetes, hypertension
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Hypertension; Stomach Neoplasms
• Other Study ID Numbers: 1210552-1