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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637350
First Posted: July 11, 2012
Last Update Posted: February 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
  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 2016
Estimated Primary Completion Date: October 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01637350     History of Changes
Other Study ID Numbers: CIH-WXN-201205001
First Submitted: July 6, 2012
First Posted: July 11, 2012
Last Update Posted: February 17, 2016
Last Verified: August 2012

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases