Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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

Official Title
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The Effect and Mechanism of Improving Diabetes by Reconstruction Methods in Gastric Cancer Patients With DM Who Receive Surgical Treatment

Conditions
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Gastric Cancer, Diabetes

Intervention / Treatment
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* Procedure: Roux-en Y gastrojejunostomy
* Procedure: Gastroduodenostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastroduodenostomy<br>Arm 1: undergo gastroduodenostomy after distal gastrectomy for gastric cancer | Procedure: Gastroduodenostomy<br>* 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.<br>|
| Experimental: Roux-en Y gastrojejunostomy<br>Arm 2: undergo Roux-en Y gastrojejunostomy after distal gastrectomy for gastric cancer | Procedure: Roux-en Y gastrojejunostomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early gastric cancer