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

Official title

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

Overview

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.

Interventions

• 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);
• 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).

Primary outcome measures

• 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 [Time frame: 5 days,4 weeks]

Secondary outcome measures (8)

• Change in nutritional status scores (NRS 2002 scale) of the two groups of patients after 4 weeks of treatment compared to baseline [Time frame: 4 weeks]
• Laboratory values after 4 weeks of treatment in the two groups: changes in total protein levels [Time frame: 4 weeks]
• Laboratory values after 4 weeks of treatment in the two groups: changes in albumin levels [Time frame: 4 weeks]
• Laboratory values after 4 weeks of treatment in the two groups: changes in globulin levels [Time frame: 4 weeks]
• Laboratory values after 4 weeks of treatment in the two groups: changes in prealbumin levels [Time frame: 4 weeks]
• Laboratory values after 4 weeks of treatment in the two groups: changes in transferrin levels [Time frame: 4 weeks]
• Weight changes from baseline after 4 weeks of treatment in two groups of patients [Time frame: 4 weeks]
• BMI changes from baseline after 4 weeks of treatment in two groups of patients [Time frame: 4 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07751367 · KBS20251217

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗