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NCT07557394Not 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

Source: ClinicalTrials.gov · Last updated 29 Apr 2026

Brief summary (registry, in English)

Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
80 (estimated)
First submitted
22 Apr 2026
Start date
1 May 2026
Primary completion date
30 Nov 2027
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NCT number
NCT07557394

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 80
  • From 1 May 2026 to the primary completion date, 30 Nov 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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;
  • Psychological cognitive impairment.

Lab values

  • Combined with intestinal obstruction, severe hepatic and renal insufficiency (Child-Pugh Class C, eGFR \< 30 ml/min), etc;

Other

  • Pregnant or lactating women;
  • It is expected that the 12-weeks follow-up will not be completed.

Who the study is looking for

  • 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%.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.