Gastric CancerNCT01375738
Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus
A study testing Roux-en Y gastrojejunostomy and Gastroduodenostomy in people with Gastric Cancer and Diabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to evaluate the applicability and efficacy of… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastric Cancer, Diabetes
- What is being tested?
- Roux-en Y gastrojejunostomy and Gastroduodenostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to May 2014
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who are older than 20 years and younger than 80 years
- Histologically confirmed gastric adenocarcinoma located lower one third of stomach
- Postoperative confirmed pT1N0, pT2N0, pT1N1
- Informed consent
Who cannot join
- Previous history of treatment for other malignancy or inflammatory disease
- Preoperative uncontrolled serious comorbidity
- Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.)
- Patient who experience any complications requiring reoperation following gastrectomy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Ji Yeong An, MD, 82-2-2228-2100, jar319@yuhs.ac
Yoo-Min Kim, MD, AUG79@yuhs.ac
About this study
Official title: The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment
This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes.
Read the detailed description
Purpose:
- To investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes
- To investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods
- To evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes
Contents:
- Evaluation of the status of diabetes in gastric cancer patients with DM after gastrectomy
- Comparison of two reconstruction types after gastrectomy Bypass duodenum and upper jejunum: Roux-en-Y gastrojejunostomy Preservation of duodenal passage: Gastroduodenostomy
- Analysis for biochemical markers reflecting diabetic status: fasting glucose, postprandial 2h glucose, HbA1c, C-peptide, lipid profile
- Correlation of parameters associated with diabetes and GI hormones
- Measurement of GI hormones which have an effect on glucose tolerance
- Insulin, glucagon, IGF-1, GLP-1, Neuropeptide Y, Ghrelin, Leptin
- Correlation of reconstruction methods, parameters of diabetes and GI hormone levels
- Evaluation of mechanism of Roux-en-Y gastrojejunostomy on controlling diabetes
- Evaluation of Feasibility of Roux-en-Y gastrojejunostomy in gastric cancer surgery in patients with DM
- Degree of high blood glucose control, the amount of antidiabetic medication, costs for DM treatment, quality of life assessment
- Analysis for the mechanism of gastrointestinal physiology to diabetes control
- Conditions
- Gastric Cancer, Diabetes
- Being tested
- Roux-en Y gastrojejunostomy, Gastroduodenostomy
- Keywords
- Early gastric cancer
- Medical subject headings
- Stomach Neoplasms, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en Y gastrojejunostomyProcedure or surgery
After subtotal gastrectomy with lymph node dissection, the jejunum is transected 25~30cm distal to the ligament of Treitz. Distal jejunum is drawn up and sutured to the gastric remnant and the proximal jejunum is anastomosed to the distal jejunum at 30~40cm from the new gastric-jejunal junction.
GastroduodenostomyProcedure or surgery
After subtotal gastrectomy with lymph node dissection, the gastric remnant is anastomosed to duodenum 1st portion with circular or linear staplers and the artificial lesser curvature is repaired with linear stapler.
| Study group | Role | What they receive |
|---|---|---|
| Gastroduodenostomy | Active comparator | Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer Receives: Procedure: Gastroduodenostomy |
| Roux-en Y gastrojejunostomy | Experimental | Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer Receives: Procedure: Roux-en Y gastrojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sugar stabilization after gastrectomy
By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.
Measured: three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ji yeong an, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375738
- Sponsor's protocol ID
- 4-2011-0109
- Status last verified
- Sep 2012
- First submitted
- 27 May 2011
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30.
PubMed 20863527Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
PubMed 34523717
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment
- ClinicalTrials.gov ID
- NCT01375738
- Acronym / sponsor ID
- 4-2011-0109
- Conditions
- Gastric Cancer, Diabetes
- Keywords
- Early gastric cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 17 Jun 2011 (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.
This study is to investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes, to investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods, and to evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes.
Detailed description
Purpose:
- To investigate the effect of gastrectomy on remission of type 2 diabetes in patients with gastric cancer and type 2 diabetes
- To investigate the mechanism of blood glucose alteration and intestinal hormonal signaling by the reconstruction methods
- To evaluate the applicability and efficacy of Roux-en-Y gastrojejunostomy after gastrectomy in gastric cancer patients with diabetes
Contents:
- Evaluation of the status of diabetes in gastric cancer patients with DM after gastrectomy
- Comparison of two reconstruction types after gastrectomy Bypass duodenum and upper jejunum: Roux-en-Y gastrojejunostomy Preservation of duodenal passage: Gastroduodenostomy
- Analysis for biochemical markers reflecting diabetic status: fasting glucose, postprandial 2h glucose, HbA1c, C-peptide, lipid profile
- Correlation of parameters associated with diabetes and GI hormones
- Measurement of GI hormones which have an effect on glucose tolerance
- Insulin, glucagon, IGF-1, GLP-1, Neuropeptide Y, Ghrelin, Leptin
- Correlation of reconstruction methods, parameters of diabetes and GI hormone levels
- Evaluation of mechanism of Roux-en-Y gastrojejunostomy on controlling diabetes
- Evaluation of Feasibility of Roux-en-Y gastrojejunostomy in gastric cancer surgery in patients with DM
- Degree of high blood glucose control, the amount of antidiabetic medication, costs for DM treatment, quality of life assessment
- Analysis for the mechanism of gastrointestinal physiology to diabetes control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroduodenostomy | Active comparator | Procedure: GastroduodenostomyArm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer |
| Roux-en Y gastrojejunostomy | Experimental | Procedure: Roux-en Y gastrojejunostomyArm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient who are older than 20 years and younger than 80 years
- Histologically confirmed gastric adenocarcinoma located lower one third of stomach
- Postoperative confirmed pT1N0, pT2N0, pT1N1
- Informed consent
Key exclusion criteria (4 listed)
- Previous history of treatment for other malignancy or inflammatory disease
- Preoperative uncontrolled serious comorbidity
- Vulnerable Subjects(pregnant women, children, cognitively impaired persons etc.)
- Patient who experience any complications requiring reoperation following gastrectomy
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 |
|---|---|---|
| Roux-en Y gastrojejunostomyAfter subtotal gastrectomy with lymph node dissection, the jejunum is transected 25~30cm distal to the ligament of Treitz. Distal jejunum is drawn up and sutured to the gastric remnant and the proximal jejunum is anastomosed to the distal jejunum at 30~40cm from the new gastric-jejunal junction. | Procedure or surgery | Roux-en Y gastrojejunostomy |
| GastroduodenostomyAfter subtotal gastrectomy with lymph node dissection, the gastric remnant is anastomosed to duodenum 1st portion with circular or linear staplers and the artificial lesser curvature is repaired with linear stapler. | Procedure or surgery | Gastroduodenostomy |
Primary outcome
Blood sugar stabilization after gastrectomy
Time frame: three months after surgery
By comparing the difference between fasting blood sugar and postprandial blood glucose, blood sugar stabilization after gastrectomy will be maesured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2012.
- Background: PubMed 20863527Yang J, Li C, Liu H, Gu H, Chen P, Liu B. Effects of subtotal gastrectomy and Roux-en-Y gastrojejunostomy on the clinical outcome of type 2 diabetes mellitus. J Surg Res. 2010 Nov;164(1):e67-71. doi: 10.1016/j.jss.2010.07.004. Epub 2010 Jul 30.
- Derived from this study: PubMed 34523717Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en Y gastrojejunostomy and Gastroduodenostomy in people with Gastric Cancer and Diabetes, run by Yonsei University at 1 site in South Korea.
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 4 inclusion and 4 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 13 Sep 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sugar stabilization after gastrectomy (time frame: three months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375738, which also lists 2 linked publications.
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 13 Sep 2012.