Gastric CancerPhase 2/3NCT01528059
Roux-en-Y Versus Billroth II Reconstruction After Subtotal Gastrectomy in Gastric Cancer Comorbid With Type II Diabetes
A Phase 2/3 study testing Stomach-small intestine reconstruction in people with Gastric Cancer and Type 2 Diabetes, run by feng Zheng at 1 site in China.
Trial summary
Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Gastric Cancer, Type 2 Diabetes
- What is being tested?
- Stomach-small intestine reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Mar 2013
- Phase
- Phase 2/3
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type 2 diabetes
- Diagnosed with gastric cancer
Who cannot join
- Type 1 diabetes
- Unresectable cancers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
DongFang Hospital
Fuzhou, Fujian, 350025
Yu Wang, M.D, 13805019453, flyfishwang@hotmail.com
ZhongDong Zhou, M.D, 13705038043, fzptwk@21cn.com
About this study
Official title: A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer Comorbid With Type 2 Diabetes
Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.
Read the detailed description
Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.
- Conditions
- Gastric Cancer, Type 2 Diabetes
- Being tested
- Stomach-small intestine reconstruction
- Keywords
- Diabetes, Gastric cancer, Gastric bypass
- Medical subject headings
- Stomach Neoplasms, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stomach-small intestine reconstructionProcedure or surgery
Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Billroth II | Active comparator | After stomach resection, the remnant stomach is connected to the jejunum. Receives: Procedure: Stomach-small intestine reconstruction |
| Roux en Y | Active comparator | After stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum. Receives: Procedure: Stomach-small intestine reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
- Fasting and postprandial glycemic levels, HbA1C
- Number of anti-diabetic drugs
- Dosage of anti-diabetic drugs
Measured: 1 year after surgery
Secondary outcomes (1)
Nutritional status assessment
- Body mass index
- Anthropometric analysis
- Plasma concentrations of albumin, pre-albumin, transferrin,and CRP
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012 (estimated)
- Study completionMar 2013 (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.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- feng Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, feng Zheng, Xiamen University
- Investigators
- Yu Wang, M.D, Principal investigator, Dongfang Hospital, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528059
- Sponsor's protocol ID
- DongFang
- Other IDs
- FNSP2009Y0039
- Status last verified
- Feb 2012
- First submitted
- 2 Feb 2012
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer Comorbid With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01528059
- Acronym / sponsor ID
- DongFang
- Conditions
- Gastric Cancer, Type 2 Diabetes
- Keywords
- Diabetes, Gastric cancer, Gastric bypass
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- feng ZhengUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 7 Feb 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.
Gastric bypass improves glycemic levels in type 2 diabetes. However, the efficacy may be varied by different gastric-small intestine reconstruction used in the procedure. There are reports that Roux en Y reconstruction may give a better result. The purpose of this study is to compare Roux en Y and Billroth II reconstruction in patients with gastric cancer comorbid with type 2 diabetes.
Detailed description
Type 2 diabetes may cause severe complications such as nephropathy and retinopathy. Additionally, it is associated with increased risk for cardiovascular events and diseases. Surgical intervention with gastric bypass has been shown to attenuate glycemic levels in obese patient comorbid with type 2 diabetes. However, since gastric bypass is not a standard procedure, surgical protocol including stomach and small intestine reconstruction may be varied. The investigators and others have found that stomach and small intestine reconstruction may affect the efficacy of diabetic treatment. In this study, the investigators will compare the efficacy of Billroth II and Roux en Y reconstruction on glycemic control in stomach cancer patients with type 2 diabetes. Both Billroth II and Roux en Y are used in stomach-small intestine reconstruction after subtotal gastrectomy. No differences in postoperative outcomes and quality of life have been reported in Billroth II and Roux en Y reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Billroth II | Active comparator | Procedure: Stomach-small intestine reconstructionAfter stomach resection, the remnant stomach is connected to the jejunum. |
| Roux en Y | Active comparator | Procedure: Stomach-small intestine reconstructionAfter stomach resection, the remnant stomach is connected to the distal jejunum while duodenum and the proximal jejunum is reconnected to jejunum. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with Type 2 diabetes
- Diagnosed with gastric cancer
Key exclusion criteria (2 listed)
- Type 1 diabetes
- Unresectable cancers
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 |
|---|---|---|
| Stomach-small intestine reconstructionBillroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes | Procedure or surgery | Billroth II, Roux en Y |
Primary outcome
Glycemic control
Time frame: 1 year after surgery
1. Fasting and postprandial glycemic levels, HbA1C 2. Number of anti-diabetic drugs 3. Dosage of anti-diabetic drugs
1 secondary outcome
Nutritional status assessment
Time frame: 1 year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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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.
Yu Wang, M.D principal investigator
Dongfang Hospital, Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stomach-small intestine reconstruction in people with Gastric Cancer and Type 2 Diabetes, run by feng Zheng 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 2 inclusion and 2 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 7 Feb 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yu Wang, M.D (13805019453, flyfishwang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: 1 year after surgery). It is what the study was designed to measure, not a finding.
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 7 Feb 2012.