New combo pill aims to ease digestion woes after pancreatic cancer surgery
NCT ID NCT07557394
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding Shouhui Tongbian capsules to standard pancreatic enzyme therapy can help people digest food better after surgery for pancreatic cancer. About 80 adults who had a Whipple procedure and have digestive issues or constipation will take part. The main goal is to measure changes in a stool marker of pancreatic function over 12 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: 18-80 years old; 2. Pathologically confirmed pancreatic cancer and underwent pancreaticoduodenectomy(involved removing 50% of the pancreas, leaving 50% of the pancreas, ensuring balanced grouping); 3. Presence of EPI symptoms (such as steatorrhea) and/or constipation (Bristol type 1-2, with \<3 bowel movements per week); 4. Have informed consent and be proficient in using smartphone apps; 5. Patients who are intended to receive treatment with either Daitong Capsules or Shouhui Tongbian Capsules, or both; 6. The patient's condition is stable and suitable for participation in this study, as confirmed by investigator; 7. 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: 1. Allergic to pancreatic enzyme (porcine-derived protein allergy) or any ingredient of Shouhui Tongbian Capsules; 2. Have a history of liver damage caused by Polygonum multiflorum; 3. Combined with intestinal obstruction, severe hepatic and renal insufficiency (Child-Pugh Class C, eGFR \< 30 ml/min), etc; 4. Pregnant or lactating women; 5. Psychological cognitive impairment. 6. It is expected that the 12-weeks follow-up will not be completed.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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