A Prospective Non-randomized Controlled Interventional Study on the Effect of Shouhui Tongbian Capsules Combined With Pancreatin Enteric-coated Capsules on Pancreatic Exocrine Function in Patients After Curative Resection for Pancreatic Cancer
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Improvement effect on pancreatic exocrine function
研究概览
简要总结
Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy.
详细描述
Patients who have undergone pancreaticoduodenectomy often face severe digestive function impairment, including exocrine pancreatic insufficiency, delayed gastric emptying, abdominal distension, constipation, and diarrhea, which significantly affect their postoperative recovery and quality of life. Currently, postoperative digestive function management primarily relies on pancreatic enzyme replacement therapy (PERT). However, monotherapy with pancreatic enzymes has limited efficacy in improving complex postoperative gastrointestinal symptoms, and patient compliance is poor, with dose adjustments lacking individualized basis. Shouhui Tongbian Capsule, a traditional Chinese medicine, has the effects of nourishing yin, invigorating qi, moistening the intestines, and promoting defecation. It is clinically used for the treatment of functional constipation and postoperative abdominal distension, showing good therapeutic effects. Existing studies have shown that Shouhui Tongbian Capsule can significantly improve postoperative bowel sound recovery time and first flatus time, and enhance patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age: 18-80 years old;
- •Pathologically confirmed pancreatic cancer and underwent pancreaticoduodenectomy(involved removing 50% of the pancreas, leaving 50% of the pancreas, ensuring balanced grouping);
- •Presence of EPI symptoms (such as steatorrhea) and/or constipation (Bristol type 1-2, with <3 bowel movements per week);
- •Have informed consent and be proficient in using smartphone apps;
- •Patients who are intended to receive treatment with either Daitong Capsules or Shouhui Tongbian Capsules, or both;
- •The patient's condition is stable and suitable for participation in this study, as confirmed by investigator;
- •Willing and able to follow the medication and follow-up plan specified in the study protocol, with an expected medication adherence rate of over 80%.
排除标准
- •Allergic to pancreatic enzyme (porcine-derived protein allergy) or any ingredient of Shouhui Tongbian Capsules;
- •Have a history of liver damage caused by Polygonum multiflorum;
- •Combined with intestinal obstruction, severe hepatic and renal insufficiency (Child-Pugh Class C, eGFR < 30 ml/min), etc;
- •Pregnant or lactating women;
- •Psychological cognitive impairment.
- •It is expected that the 12-weeks follow-up will not be completed.
研究组 & 干预措施
experimental group
干预措施: Shouhui Tongbian Capsules (Drug)
experimental group
干预措施: Pancreatin Enteric-Coated Capsules (Drug)
control group
干预措施: Pancreatin Enteric-Coated Capsules (Drug)
结局指标
主要结局
Improvement effect on pancreatic exocrine function
时间窗: 12 weeks after treatment
Change in fecal elastase-1 concentration (μg/g) from baseline to Week 12
次要结局
未报告次要终点
研究者
Wu Chuanxing
Associate Chief Physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine