Prospective Study for the Effects of High Dose Pancreatic Enzyme Replacement Therapy on Body Weight, Quality of Life, and Nutritional Assessment After Pancreatoduodenectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 6
- 主要终点
- Change from Baseline in body weight at 3 months after medication
研究概览
简要总结
Up to now, the studies concerning nutritional assessment after pancreatic resection were rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant benefit in terms of nutritional status. This study is a multicenter randomized phase IV study by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status after pancreaticoduodenectomy.
详细描述
There are not enough studies evaluating nutritional parameters in patients with pancreatic resection. After pancreatic surgery, there are several ways to improve patient condition in terms of quality of life including nutrition.
In the investigators previous study, pancreatic enzyme supplement through the administration of Norzyme® 25000 IU containing lipase 25000 IU, amylase 22500 IU, and protease 1250 IU after various type of pancreatectomy to improve quality of life and nutritional status failed to prove its effectiveness. After administration of low-dose Norzyme® (25000 IU), some patients showed weight gain, but statistically significant conclusions were not obtained mainly because of various types of pancreatectomy and low supplementary dosage of pancreatic enzyme.
Therefore, the investigators design this study to find out the effect of high-dose Norzyme® (40000 IU) on weight gain, quality of life, stool habit change, and nutritional status in patients with pancreaticoduodenectomy. The investigators will evaluate the effectiveness and adequacy of high-dose pancreatic supplementary treatment through a randomized, placebo-using, single-blinded, and multicenter study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Age between 18 and 75 years
- •ECOG performance status : 0,1,2
- •Patients who underwent pancreaticoduodenectomy or pylorus preserving pancreaticoduodenectomy
- •stool elastase ≤200, preoperatively and postoperatively
- •Patients consented to this study
排除标准
- •Patients with comorbidities such as liver cirrhosis, chronic renal failure, heart failure, and inflammatory bowel disease which can affect the assessment of quality of life or nutritional status
- •Patients underwent major abdominal organ surgery such as gastrectomy and colon resection which can affect the assessment of quality of life or nutritional status
- •Patients with locoregional recurrence or distant metastasis
- •Patients which were not able to progress diet and medication within 10 days after surgery
- •Patients with pork allergy
研究组 & 干预措施
Norzyme® 40000 IU
Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.
干预措施: Norzyme® 40000 IU (Drug)
Placebo
Single capsule of placebo drug with the same appearance of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal. The formulation and the form of placebo is same with the Norzyme® 40000 IU. Placebo contains microcrystalline cellulose as the main component, titanium oxide, colloidal silica, yellow iron oxide, brown iron oxide, black iron oxide, magnesium stearate, triethyl citrate, talc, and simethicone emulsion in very small amount
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in body weight at 3 months after medication
时间窗: 3 months after medication
Body weight will be measured 3 times during the entire study period, once preoperatively and two times postoperatively. After surgery, weight will be measured before medication and at the 3 months after medication.These serial weight measurements will be analyzed to figure out changes in body weight over time.
次要结局
- Change from Baseline in Nutritional Status at 3 months after medication(3 months after medication)
- Change from baseline in stool habit at 3 months after medication(3 months after medication)