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

NCT07557394 | Not Yet Recruiting Phase 4

• 1 other identifier: 20251210034657959
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

pancreaticoduodenectomy; PD; Pancreatic exocrine function

Outcome Measures

Primary Outcomes (1)

• Improvement effect on pancreatic exocrine function

  Change in fecal elastase-1 concentration (μg/g) from baseline to Week 12

  12 weeks after treatment

Study Arms (2)

experimental group

EXPERIMENTAL

Drug: Shouhui Tongbian Capsules; Drug: Pancreatin Enteric-Coated Capsules

control group

ACTIVE COMPARATOR

Drug: Pancreatin Enteric-Coated Capsules

Interventions

Shouhui Tongbian Capsules DRUG

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.

Also known as: Pancreatin Enteric-Coated Capsules

experimental group

Pancreatin Enteric-Coated Capsules DRUG

Pancreatin enteric-coated capsules are administered at the clinically conventional dosage,for a continuous period of 12 weeks.

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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;
• Psychological cognitive impairment.
• It is expected that the 12-weeks follow-up will not be completed.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04