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
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Enrollment
- 80
- Primary Endpoint
- Improvement effect on pancreatic exocrine function
Overview
Brief Summary
Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%.
Exclusion Criteria
- •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.
Arms & Interventions
experimental group
Intervention: Shouhui Tongbian Capsules (Drug)
experimental group
Intervention: Pancreatin Enteric-Coated Capsules (Drug)
control group
Intervention: Pancreatin Enteric-Coated Capsules (Drug)
Outcomes
Primary Outcomes
Improvement effect on pancreatic exocrine function
Time Frame: 12 weeks after treatment
Change in fecal elastase-1 concentration (μg/g) from baseline to Week 12
Secondary Outcomes
No secondary outcomes reported
Investigators
Wu Chuanxing
Associate Chief Physician
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine