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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| The First Hospital of Jilin University | OTHER |
| Shanghai Jiao Tong University School of Medicine | OTHER |
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This is a prospective, multi-center, randomized controlled trial to compare Billroth II reconstruction versus conventional Roux-en-Y reconstruction versus long limb Roux-en-Y reconstruction for glycemic control in patients with concurrent type 2 diabetes and gastric cancer.
Billroth I, Billroth II, or Roux-en-Y procedure follows gastrectomy to reconstruct the gastrointestinal tract. Billroth I procedure restores the normal configuration of the gastrointestinal tract and Billroth II and Roux-en-Y procedure involve the creation of duodenal switch which is thought to be responsible for metabolic effects by altering enteric hormones. Accordingly, several retrospective studies reported that Billroth I reconstruction has less effect on diabetes compared to Billroth II and Roux-en-Y reconstruction. While little is known about different effects of Billroth II and Roux-en-Y procedure, a study retrospectively show that Roux-en-Y procedure has significantly higher rate of T2DM remission than Billroth II procedure. Investigators conduct a randomized controlled trial to control possible confounders arising from diverse metabolic effects of cancer and minimize differences in treatment regimen among patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long limb Roux-en-Y reconstruction | Active Comparator | Long limb Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer. |
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| Conventional Roux-en-Y reconstruction | Active Comparator | Conventional Roux-en-Y reconstruction method follows subtotal gastrectomy for gastric cancer. |
|
| Billroth II reconstruction | Active Comparator | Billroth II reconstruction method follows subtotal gastrectomy for gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long limb Roux-en-Y reconstruction after subtotal gastrectomy | Procedure | The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb). |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5% | The proportion of subjects with HbA1c < 6.5% without diabetes medications | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%) | The number of days from randomization to the visit date when HgA1c is first observed to be < 6.5% (or 6.0%) post-randomization | Every visit date, assessed up to 12, 24, and 36 months |
| Success rate of biochemical resolution of diabetes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sungsoo Park, MD, PhD | Contact | +82 2 920 6772 | kugspss@korea.ac.kr | |
| Yeongkeun Kwon, MD, PhD | Contact | +82 2 920 6772 | kukwon@korea.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sungsoo Park, MD, PhD | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
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| Guangdong Provincial Hospital of Traditional Chinese Medicine |
| OTHER |
| Korea University Ansan Hospital | OTHER |
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|
| Conventional Roux-en-Y reconstruction after subtotal gastrectomy | Procedure | The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb). |
|
| Billroth II reconstruction after subtotal gastrectomy | Procedure | The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop) |
|
Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c ≤ 6% (with or without diabetes medication) |
| 12 months, 24 months, 36 months |
| Success rate of biochemical improvement of diabetes | Success rate of biochemical improvement of diabetes at 12, 24, 36 months as measured by HbA1c <6.5% (with or without diabetes medication) | 12 months, 24 months, 36 months |
| Change in glycated hemoglobin from baseline | percent change | 12 months, 24 months, 36 months |
| Change in fasting plasma glucose level from baseline | percent change | 12 months, 24 months, 36 months |
| Change in total cholesterol | Percent change in total cholesterol at 12 months, 24 months, 36 months | 12 months, 24 months, 36 months |
| Change in triglyceride | Percent change in triglyceride at 12 months, 24 months, 36 months | 12 months, 24 months, 36 months |
| Change in High-density Lipoprotein (HDL) | Percent change in high-density lipoprotein (HDL) at 12 months, 24 months, 36 months | 12 months, 24 months, 36 months |
| Change in Low-density Lipoprotein (LDL) | Percent change in Low-density Lipoprotein (LDL) at 12 months, 24 months, 36 months | 12 months, 24 months, 36 months |
| Use of diabetes medication | number of diabetes medication at 12 months, 24 months, 36 months | 12 months, 24 months, 36 months |
| Patients with hypertension and/or requiring antihypertensive therapy | number and percentage | 12 months, 24 months, 36 months |
| Patients with dyslipidemia and/or requiring cholesterol lowering medications | number and percentage | 12 months, 24 months, 36 months |
| Mean and change in weight and BMI from baseline | mean and percent change | 12 months, 24 months, 36 months |
| Mean and change in waist, hip, and thigh circumference from baseline | mean and percent change | 12 months, 24 months, 36 months |
| Change in SF-36 scores of questionnaire from baseline | The MOS 36-Item Short-Form Health Survey | 12 months, 24 months, 36 months |
| Change in High-sensitivity C-reactive Protein (Hs-CRP) | percent change in high-sensitivity C-reactive protein (hs-CRP) | 12 months, 24 months, 36 months |
| Change in Systolic Blood Pressure (SBP) | Change in Systolic Blood Pressure (SBP) at 12 months, 24 months, 36 months | 12 months, 24 months, 36 months |
| The Side Effects and /or Complications of each surgical procedure | number of the Side Effects and /or Complications of each surgical procedure | 12 months, 24 months, 36 months |
| The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5% | The proportion of subjects with HbA1c < 6.5% without diabetes medications | 24 months, 36 months |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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