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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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