Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes

Gastric Cancer Clinical Trial

Official title:

The Effect of Blood Glucose to Different Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01637350
• Other study ID #: CIH-WXN-201205001
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 6, 2012
• Last updated: February 14, 2016
• Start date: August 2012
• Est. completion date: December 2016

Study information

• Verified date: August 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.

Description:

Different digestive tract reconstruction will affect the blood glucose level of gastric cancer with type 2 diabetes. Subtotal gastrectomy with Billroth II reconstruction and total gastrectomy with Roux-en-Y reconstruction may help to improve glycaemic control which includes fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of gastric cancer patients with type 2 diabetes.

The investigators will observed fasting blood glucose, postprandial blood glucose, glycosylated hemoglobin, C -peptide and body weight of the patients preoperation, 14 days postoperation 3 month and 6month postoperation. The investigators will observed the effect of blood glucose to different digestive tract reconstruction after gastrectomy of gastric cancer with type 2 diabetes

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old,gastric cancer ,can be performed operation

2. with type 2 diabetes,fasting blood glucose > 6.1mmol/L

3. without serious underlying diseases which may affect the metabolism and nutrient uptake

4. without serious underlying diseases which may affect anesthesia and operation

5. can be performed subtotal or total gastrectomy, predicted survival period > 6months

6. no other abdominal operation

7. preoperation consultation

8. informed consent

Exclusion Criteria:

1. recurrent,metastasis or die

2. patient requests for quit

3. pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• digestive tract reconstruction
Subtotal gastrectomy with Billroth? or Billroth?, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China,