The Effect of PERT on Postoperative Complications and Physiological Status in Patients Undergoing Pancreaticoduodenectomy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Abdominal Skeletal Muscle Index (SMI)
研究概览
简要总结
A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy, with the aim of exploring:
- The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy;
- The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy;
- The personalized full process nutrition management strategies based on risk factor stratification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender unlimited, 18-80 years old;
- •Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases;
- •Voluntary testing with informed consent.
排除标准
- •Pregnant women and lactating women
- •Patients with distant metastasis based on tumor staging before surgery;
- •Tumor recurrence;
- •Refuse to sign the consent form.
研究组 & 干预措施
PERT Group
After surgery, resume diet and begin receiving standard PERT treatment (2 capsules per meal, 1 capsule per snack, taken with meals, starting at a dose of 40000 to 50000 units of lipase) for 8 weeks.
干预措施: Pancreatin Enteric-coated Capsules (Drug)
Placebo Group
Follow the routine treatment plan for pancreatic tumors during the perioperative period.
干预措施: Routine treatment plan (Other)
结局指标
主要结局
Abdominal Skeletal Muscle Index (SMI)
时间窗: 8 weeks post-operation
Measurement of abdominal skeletal muscle area at the third lumbar spine plane using abdominal plain scan CT and comparison of baseline level SMI change rate.
次要结局
- Postoperative complications(8 weeks post-operation)
- Nutritional indicators(8 weeks post-operation)
研究者
Weishen WANG
Principal Investigator
Ruijin Hospital