Long Limb Roux-en Y Reconstruction After Gastrectomy As A Potential Cure for Type 2 Diabetes Mellitus in Non-Obese Gastric Cancer Patients - a Pilot Project to Validate a Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Morbidity
研究概览
简要总结
We grafted the concept of metabolic surgery (long limb Roux-en Y reconstruction) into gastric cancer surgery. This study aimed to investigate the safety and efficacy of long limb Roux-en Y reconstruction after gastrectomy in non-obese type II diabetes with gastric cancer.
详细描述
Type II diabetes in the world is increasing rapidly, and it is known that patients with type II diabetes with morbid obesity that underwent bariatric surgery have resolution of impaired glucose metabolism.
In Asia, most type II diabetes are not morbidly obese and still, it is controversy whether metabolic surgery is effective or not in non-morbid obese patients. As life expectancy is increased, the number of patients with gastric cancer and T2DM is increased as well.
Recently, we studied the outcome of T2DM after gastrectomy and conventional reconstruction in non-obese gastric cancer patients.(Kim JW et al, World J Gastroenterol 2012;18:49) The study was a large-series retrospective study including about 400 patients and the result regarding DM improvement was not satisfactory. Based on our previous results, it is needed to find more effective way to resolve the type II diabetes in gastrectomized patients with gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed gastric cancer with potentially curable state
- •Non-obese (Body mass index: less than 30 kg/m2)
- •Have a history of Type 2 DM over 6 months (diagnosed by ADA criteria)
- •HBA1c: more than 6.5 %, or Fasting glucose: more than 126 mg/dl (7.0mmol/L) or 2-h plasma glucose: more than 200mg/dl during an OGTT or classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose: more than 200mg/dl
- •Anti-GAD antibody (-), Anti-islet antibody (-)
- •C-peptide level: above 1ng/ml
排除标准
- •Patient who receive non-curative operation
- •Patient who have less than one year life expectancy
- •Pregnant patient
- •Acute inflammation status patient
- •Chronic renal disease patient (Serum creatin level: more than 1.5mg/dl)
- •Chronic liver disease patient (Serum AST or ALT level: more than twice of upper limit of normal range)
- •Have a history of receiving medications such as dipeptidyl peptidase IV(DPP- IV) inhibitor or glucagon like peptide-I (GLP-I) analogue
结局指标
主要结局
Morbidity
时间窗: Until end of study (on average 14.8 months)
For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected. \*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix "d" (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. For the evaluation of long-term safety, the patients were evaluated every month after discharge.
HbA1c
时间窗: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)). HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.
Hemoglobin
时间窗: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.
Albumin
时间窗: Before operation , 6 months after operation, Until end of study (on average 14.8 months)
For the evaluation of long-term safety, albumin was measured to determine malnutrition.
Operation Related Mortality
时间窗: Until end of study (on average 14.8 months)
Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.
次要结局
- Matsuda Index(Before operation , 6 months after operation, Until end of study (on average 14.8 months))
- QUICKI(Before operation , 6 months after operation , Until end of study (on average 14.8 months))
- HOMA-IR(Before operation , 6 months after operation, Until end of study (on average 14.8 months))
- HOMA-B(Before operation , 6 months after operation, Until end of study (on average 14.8 months))
- Body Mass Index(Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months))
- Matsuda Index : Good Response Group(Before operation , 6 months after operation, Until end of study (on average 14.8 months))
- QUICKI : Good Response Group(Before operation, 6 months after operation, Until end of study (on average 14.8 months))
- HOMA-IR : Good Response Group(Before operation, 6 months after operation, Until end of study (on average 14.8 months))
- HOMA-B : Good Response Group(Before operation, 6 months after operation, Until end of study (on average 14.8 months))
- Body Mass Index : Good Response Group(Before operation, 6 months after operation, Until end of study (on average 14.8 months))
- HbA1c : Good Response Group(Before operation, 6 months after operation, Until end of study (on average 14.8 months))
- Hemoglobin : Good Response Group(Before operation, 6 months after operation, Until end of study (on average 14.8 months))
- Albumin : Good Response Group(Before operation, 6 months after operation, Until end of study (on average 14.8 months))
研究者
Seung Ho Choi
Chief of surgery
Gangnam Severance Hospital