A Prospective Non-randomized Controlled Interventional Study on the Effect of Shouhui Tongbian Ca… (NCT07557394) | Clinical Trial Compass
Not Yet RecruitingPhase 4
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
80 participantsStarted 2026-05-01
Plain-language summary
Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy.
Who can participate
Age range18 Years – 80 Years
SexALL
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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;
✕
What they're measuring
1
Improvement effect on pancreatic exocrine function
Timeframe: 12 weeks after treatment
Trial details
NCT IDNCT07557394
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine