A Study on the Efficacy of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery

A Multicenter, Open-Label, Randomized Controlled Trial on the Efficacy and Safety of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery

This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based medicine and promote standardized treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Exocrine Insufficiency, Adul
• Intervention / Treatment: Drug: High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet; Drug: Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jihui Hao M.D.; Phone Number: 022-23524155; Email: ec_tjcih@126.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300000
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Jihui Hao M.D.; Phone Number: 022-23524155; Email: ec_tjcih@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 75 years (inclusive of boundary values), regardless of gender;
• History of prior gastrointestinal surgical treatment, including but not limited to:

I. Post-pancreatectomy patients within 3-6 months (e.g., distal pancreatectomy, mid-pancreatectomy, total pancreatectomy, pancreatoduodenectomy); II. Post-gastrectomy patients within 2-6 months (e.g., partial gastrectomy excluding total gastrectomy);

• For tumor patients, the primary tumor stage before or during surgery must be Stage I or II (AJCC 8th edition). Patients in the interval between anti-tumor treatments must have undergone a washout period exceeding 28 days to avoid interference from anti-tumor therapy on this study;
• Diagnosis of pancreatic exocrine insufficiency (PEI) based on comprehensive assessment by the investigator considering medical history, symptoms, nutritional status, and pancreatic function;
• Gastrointestinal Quality of Life Index (GIQLI) score ≤ 105 points;
• Stable postoperative condition without systemic infection, anastomotic leak, or other severe postoperative complications;
• Participants fully understand the study and voluntarily sign a written informed consent form approved by the ethics committee.

Exclusion Criteria:

• Known allergy to any component of micafungin pancreatic enzyme tablets;
• Patients with acute pancreatitis or acute exacerbation during active phase of chronic pancreatitis, or those with known contraindications listed in the product label;
• Patients with rare inherited fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency
• Gastrointestinal obstruction;
• Use of other digestive enzyme replacement therapies during the study period;
• Coexisting decompensated cirrhosis, active hepatitis with significant hepatic dysfunction, or other definite severe chronic diseases clearly affecting gastrointestinal motility and absorption (e.g., active inflammatory bowel disease); diabetes is not an exclusion criterion but must be documented in detail regarding type and treatment regimen;
• Tumor patients who had distant metastasis (M1) preoperatively (AJCC 8th edition) or locally advanced unresectable tumors requiring non-curative surgery. Patients who received neoadjuvant chemotherapy/radiotherapy/targeted therapy or other systemic anti-tumor treatments prior to or during surgery, even if the primary tumor was staged as Stage I or II;
• Post-gastrointestinal surgery patients diagnosed clinically with gastroparesis, or meeting any of the following criteria for diagnosing delayed gastric emptying (DGE):

I.Chronic refractory gastroparesis: duration > 6 months post-surgery, with persistent symptoms at moderate or greater severity despite standardized prokinetic therapy (e.g., metoclopramide, domperidone, erythromycin); II.Severe gastroparesis symptoms present at screening, which are the primary reason for patient visit; the researcher assesses symptom severity as equivalent to or worse than symptoms potentially caused by PEI (e.g., steatorrhea); III.Invasive interventions due to gastroparesis: such as placement of jejunal feeding tube, pyloric dilation, or surgical reconstruction, and still dependent on these measures for nutritional support;

• Currently participating in another clinical trial, or recently completed another clinical trial without having reached the required washout period (within 28 days);
• Other patients judged by the investigator as unsuitable for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High-dose group; Oryz-Aspergillus Enzyme And Pancreatin Tablet	Drug: High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet; High-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet, 5 tablets each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days);
Experimental: Low-dose group; Oryz-Aspergillus Enzyme And Pancreatin Tablet	Drug: Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet; Low-dose group: Oral study drug:Oryz-Aspergillus Enzyme And Pancreatin Tablet, 1 tablet each time, three times daily, taken with each main meal or after meals, continuous administration for 4 weeks (28 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gastrointestinal Symptom Rating Scale (GSRS) from baseline in the two groups of patients before treatment, after 5 days of treatment, and after 4 weeks of treatment	Scale Full Name: Gastrointestinal Symptom Rating Scale (GSRS) The total score ranges from 15 (lowest, no symptoms) to 105 (highest, all symptoms extremely severe). Higher scores mean a worse outcome.	5 days,4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nutritional status scores (NRS 2002 scale) of the two groups of patients after 4 weeks of treatment compared to baseline	Full name of the scale: Nutritional Risk Screening 2002 (NRS-2002) The NRS-2002 uses a weighted scoring system with a total score ranging from from 0 points (lowest) to 7 points (highest), consisting of four independent modules: disease severity score, nutritional status impairment score, age adjustment, and final integrated assessment criteria. A patient is considered to have a nutritional risk only if the total score is ≥3, warranting further nutritional assessment and medical nutrition intervention. higher scores mean a worse outcome	4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in total protein levels		4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in albumin levels		4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in globulin levels		4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in prealbumin levels		4 weeks
Laboratory values after 4 weeks of treatment in the two groups: changes in transferrin levels		4 weeks
Weight changes from baseline after 4 weeks of treatment in two groups of patients	weight in kilograms	4 weeks
BMI changes from baseline after 4 weeks of treatment in two groups of patients	weight and height will be combined to report BMI in kg/m^2	4 weeks

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 18, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: August 6, 2026
• First Posted (Actual): August 7, 2026

Study Record Updates

• Last Update Posted (Actual): August 7, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Exocrine Pancreatic Insufficiency; Hydrolases; Enzymes; Enzymes and Coenzymes; Complex Mixtures; Pancreatic Extracts; Tissue Extracts; Pancreatin
• Other Study ID Numbers: KBS20251217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No