NCT01637350

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

August 1, 2012

Enrollment Period

4.2 years

First QC Date

July 6, 2012

Last Update Submit

February 14, 2016

Conditions

Study Arms (4)

Subtotal gastrectomy , BillrothⅠ

Procedure: digestive tract reconstruction

Subtotal gastrectomy , BillrothⅡ

Procedure: digestive tract reconstruction

total gastrectomy, jejunal interposition

Procedure: digestive tract reconstruction

total gastrectomy , Roux-en-Y

Procedure: digestive tract reconstruction

Interventions

Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction

Also known as: no other names
Subtotal gastrectomy , BillrothⅠSubtotal gastrectomy , BillrothⅡtotal gastrectomy , Roux-en-Ytotal gastrectomy, jejunal interposition

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years old,gastric cancer ,can be performed operation
  • with type 2 diabetes,fasting blood glucose \> 6.1mmol/L
  • without serious underlying diseases which may affect the metabolism and nutrient uptake
  • without serious underlying diseases which may affect anesthesia and operation
  • can be performed subtotal or total gastrectomy, predicted survival period \> 6months
  • no other abdominal operation
  • preoperation consultation
  • informed consent

You may not qualify if:

  • recurrent,metastasis or die
  • patient requests for quit
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Zhao Yan, Doctor

    Tianjin Medical University Cancer Institute and Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 11, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

February 17, 2016

Record last verified: 2012-08

Locations