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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01637350
First received: July 6, 2012
Last updated: February 14, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention
Gastric Cancer
Procedure: digestive tract reconstruction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Blood Glucose to Different Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subtotal gastrectomy , BillrothⅠ Procedure: digestive tract reconstruction
Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction
Other Name: no other names
Subtotal gastrectomy , BillrothⅡ Procedure: digestive tract reconstruction
Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction
Other Name: no other names
total gastrectomy, jejunal interposition Procedure: digestive tract reconstruction
Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction
Other Name: no other names
total gastrectomy , Roux-en-Y Procedure: digestive tract reconstruction
Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction
Other Name: no other names

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

gastric cancer with type 2 diabetes,18~75 years old,without serious underlying diseases

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637350

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Director: Zhao Yan, Doctor Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01637350     History of Changes
Other Study ID Numbers: CIH-WXN-201205001
Study First Received: July 6, 2012
Last Updated: February 14, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Stomach Neoplasms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 26, 2014