Surgical TreAtment for Obesity Related Disease and Onco-Metabolic Surgery

Официальное название

A Randomized Controlled Trial Comparing 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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Long limb Roux-en-Y reconstruction after subtotal gastrectomy
  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).
• Процедура Conventional Roux-en-Y reconstruction after subtotal gastrectomy
  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).
• Процедура Billroth II reconstruction after subtotal gastrectomy
  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)

Первичные конечные точки

• The success rate of biochemical improvement of diabetes as measured by HbA1c < 6.5% [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Time to first occurence of glycated hemoglobin < 6.5% (or 6.0%) [Срок оценки: Every visit date, assessed up to 12, 24, and 36 months]
• Success rate of biochemical resolution of diabetes [Срок оценки: 12 months, 24 months, 36 months]
• Success rate of biochemical improvement of diabetes [Срок оценки: 12 months, 24 months, 36 months]
• Change in glycated hemoglobin from baseline [Срок оценки: 12 months, 24 months, 36 months]
• Change in fasting plasma glucose level from baseline [Срок оценки: 12 months, 24 months, 36 months]
• Change in total cholesterol [Срок оценки: 12 months, 24 months, 36 months]
• Change in triglyceride [Срок оценки: 12 months, 24 months, 36 months]
• Change in High-density Lipoprotein (HDL) [Срок оценки: 12 months, 24 months, 36 months]
• Change in Low-density Lipoprotein (LDL) [Срок оценки: 12 months, 24 months, 36 months]
• Use of diabetes medication [Срок оценки: 12 months, 24 months, 36 months]
• Patients with hypertension and/or requiring antihypertensive therapy [Срок оценки: 12 months, 24 months, 36 months]
• Patients with dyslipidemia and/or requiring cholesterol lowering medications [Срок оценки: 12 months, 24 months, 36 months]

Критерии участия

Критерии включения

• Distal gastric adenocarcinoma diagnosed pathologically under preoperative endoscopic biopsy, and clinical stage I-II
• Body mass index ≥ 23 kg/m2
• Type 2 diabetes and HbA1c ≥ 6.5%

Критерии исключения

• Insulin usage for glycemic control at the time of screening evaluation
• Prior gastrointestinal surgery including splenectomy, hepatobiliary and pancreatic surgery (except hemorrhoidectomy, herniorrhaphy, and appendectomy)
• Abdominal, thoracic, pelvic and/or obstetric-gynecologic surgery within 3 months
• Cardiovascular conditions including significant known CAD, uncompensated congestive heart failure, history of stroke, or uncontrolled hypertension. Subjects with CAD that have been successfully treated with CABG or PCI, and have no evidence of active ischemia are eligible
• Kidney disease including renovascular hypertension, renal artery stenosis, or end-stage renal disease
• Chronic liver disease including liver cirrhosis, alpha-1 antitrypsin deficiency
• Gastrointestinal disorders including inflammatory bowel disease (Crohn's disease or ulcerative colitis) or any malabsorptive disorders
• Psychiatric disorders including dementia, active psychosis, history of suicide attempts, alcohol or drug abuse within 12 months
• Severe pulmonary disease defined as FEV1 <50% of predicted value
• Anemia defined as hemoglobin less than 8 in females and 10 in males
• Malignancy within 5 years (except squamous cell and basal cell cancer of the skin). Subjects diagnosed with early or stage I cancer than have been successfully treated are eligible per investigator discretion
• Frail elderly (Rockwood Clinical Frailty Scale ≥5)
• Any condition or major illness that, in the investigator's judgement, places the subject at undue risk by participating in the study
• Unable to understand the risks, realistic benefits and compliance requirements of each program
• Use of investigational therapy or participation in any other clinical trial within 3 months
• Geographic inaccessibility
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Korea University Anam Hospital — Seoul

Идентификаторы

NCT: NCT04284943 · STARDOM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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