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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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);
• Препарат 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).

Первичные конечные точки

• 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 [Срок оценки: 5 days,4 weeks]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07751367 · KBS20251217

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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