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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643811
• Other study ID #: 1210552-1
• Status: Completed
• Phase: N/A
• First received: July 11, 2012
• Last updated: March 23, 2016
• Start date: April 2012
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Gastric Cancer
• Hypertension
• Stomach Neoplasms

Intervention

Procedure:
• gastrectomy
subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy
• Endoscopic submucosal dissection
endoscopic submucosal dissection

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Kyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No