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| Name | Class |
|---|---|
| Kyungpook National University Chilgok Hospital | OTHER |
| Samsung Medical Center | OTHER |
| Asan Medical Center | OTHER |
| Seoul National University Bundang Hospital |
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Recently, the concept of "Onco-metabolic surgery" has emerged, and it is a theory that if anastomosis bypassing the duodenum and upper jejunum is performed after gastrectomy in gastric cancer patients with type 2 diabetes, diabetes can be expected to improve. The authors would like to compare and analyze the effect of long bowel Luwai gastrointestinal anastomosis in gastric cancer patients with type 2 diabetes in a multicenter prospective manner with that of type 2 diabetes gastric cancer patients who underwent a conventional Luwai gastrointestinal anastomosis.
<Research Design>
Primary Endpoint
It examines whether there is a statistically significant difference in the proportion of patients with improved blood sugar control one year after surgery.
Here, "Improvement of blood sugar control" includes all of the following three cases (complete remission, partial remission and improvement)
Secondary Endpoint
<Method of research>
This study is a comparative study conducted with multicenter, prospective randomization.
How to operate
Randomization is performed according to a table using https://www.sealedenvelope.com/ , and in order to ensure a balanced distribution between the two groups, stratified block randomization is performed by each institution participating in this clinical trial. Therefore, the study subjects will be randomly assigned to either the research group or the control group at a ratio of 1:1 within the participating institution.
Research group (Long bowel Ruwai anastomosis group)
Control (Existing Ruwai Anastomosis Group)
Analysis method Among the patients to be studied in this study, sex and age of the study group scheduled to perform a long bowel Luwai anastomosis and the control group patients scheduled to perform a conventional Luwai anastomosis, the medical history period of diabetes before surgery, body obesity at 1, 3, and 12 months before and after surgery, fasting blood sugar levels, and glycated hemoglobin levels are compared. Blood is collected for the preoperative and postoperative tests (30 minutes, 60 minutes, 120 minutes after loading) in the study group and the control group and the hormone and related components (insulin, C-peptide, Adiponectin, Leptin, Ghrelin, GLP-1, GIP, PYY) that are expected to be related to metabolic control and diabetes improvement effects are investigated and analyzed.
In addition, the degree of improvement in blood sugar control (no improvement, improvement: switching from insulin injection to oral hypoglycemic agents and reducing the dose of diabetic drugs, partial remission: maintaining fasting blood sugar from 100 to 125 without taking diabetic drugs, maintaining glycated hemoglobin 6 to 6.4 and complete remission: maintaining less than 100 fasting blood sugar without taking diabetic drugs) in the two groups is compared to examine the difference in blood sugar control effects according to changes in the length of anastomosis. In addition, we would like to conduct an analysis regarding the improvement of the plasma control effect to find out which factors can be the necessary requirements for improving diabetes control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicenter Prospective Randomized Controlled Study | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| long-limb Roux-en-Y gastrojejunostomy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1)Primary Endpoint | Rate of more than improvement in diabetic control - HbA1c <6.5%, FBS 125 mg/dL & not increase in antidiabetic medication requirement | one year after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 2)Secondary Endpoint | Concentration of HbA1c & FBS in postoperative 1 year Concentration of gut hormones related with diabetic control (Adiponectin, Ghrelin, Leptin, GLP-1 & GIP) | one year after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Gurogu | 08308 | South Korea |
Age, gender, weight, BMI, Inbody (Option), duration of diabetes and diabetes treatment drugs, comorbidities other than diabetes, blood tests
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| OTHER |
| Kyung Hee University Hospital at Gangdong | OTHER |
| Kosin University Gospel Hospital | OTHER |
| Dankook University | OTHER |
| Korea University Ansan Hospital | OTHER |
| Seoul National University Hospital | OTHER |
| Gangnam Severance Hospital | OTHER |
| Keimyung University Dongsan Medical Center | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Gyeongsang National University Hospital | OTHER |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |