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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 and 75 years (inclusive of boundary values), regardless of gender;

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet
  • Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet

Treatment groups

150 Participants
are divided into 2 treatment groups