Gastric CancerNCT01637350
Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes
An observational study of Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- digestive tract reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: gastric cancer with type 2 diabetes,18~75 years old,without serious underlying diseases
Who may be able to join
- 18-75 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
Who cannot join
- recurrent,metastasis or die
- patient requests for quit
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: The Effect of Blood Glucose to Different Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes
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.
Read the 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
- Conditions
- Gastric Cancer
- Being tested
- digestive tract reconstruction
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digestive tract reconstructionProcedure or surgery
Also called no other names
Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Subtotal gastrectomy , BillrothⅠ | Not described Receives: Procedure: digestive tract reconstruction | |
| Subtotal gastrectomy , BillrothⅡ | Not described Receives: Procedure: digestive tract reconstruction | |
| total gastrectomy, jejunal interposition | Not described Receives: Procedure: digestive tract reconstruction | |
| total gastrectomy , Roux-en-Y | Not described Receives: Procedure: digestive tract reconstruction |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao Yan, Doctor, Study director, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637350
- Sponsor's protocol ID
- CIH-WXN-201205001
- Status last verified
- Aug 2012
- First submitted
- 6 Jul 2012
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Glucose to Different Digestive Tract Reconstruction After Gastrectomy of Gastric Cancer With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01637350
- Acronym / sponsor ID
- CIH-WXN-201205001
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gastric cancer with type 2 diabetes,18~75 years old,without serious underlying diseases
Key inclusion criteria (8 listed)
- 18-75 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
Key exclusion criteria (3 listed)
- recurrent,metastasis or die
- patient requests for quit
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digestive tract reconstructionAlso: no other namesSubtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction | Procedure or surgery | Subtotal gastrectomy , BillrothⅠ, Subtotal gastrectomy , BillrothⅡ, total gastrectomy , Roux-en-Y, total gastrectomy, jejunal interposition |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao Yan, Doctor study director
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.