Pancreatic Exocrine Insufficiency, Adul
Conditions
Brief summary
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
DRUGHigh-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);
DRUGLow-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).
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 5 days,4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in nutritional status scores (NRS 2002 scale) of the two groups of patients after 4 weeks of treatment compared to baseline | 4 weeks | 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 |
| 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 | 4 weeks | weight in kilograms |
| BMI changes from baseline after 4 weeks of treatment in two groups of patients | 4 weeks | weight and height will be combined to report BMI in kg/m\^2 |
Countries
China
Contacts
CONTACTJihui Hao M.D.
Outcome results
None listed