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

April 22, 2026 updated by: Wu Chuanxing, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Exploratory evaluation comparing the addition of Shouhui Constipation Capsules to standard pancreatic enzyme therapy for improving exocrine pancreatic function in patients after pancreaticoduodenectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Drug: Shouhui Tongbian Capsules
Shouhui Tongbian Capsules are taken orally, 2 capsules per dose, 3 times daily;Pancreatin enteric-coated capsules are administered at the clinically conventional dosage; for a continuous period of 12 weeks.
Other Names:
  • Pancreatin Enteric-Coated Capsules
Drug: Pancreatin Enteric-Coated Capsules
Pancreatin enteric-coated capsules are administered at the clinically conventional dosage,for a continuous period of 12 weeks.
Active Comparator: control group
Drug: Pancreatin Enteric-Coated Capsules
Pancreatin enteric-coated capsules are administered at the clinically conventional dosage,for a continuous period of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20251210034657959

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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