[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pancreatic-exocrine-insufficiency-adul\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pancreatic-exocrine-insufficiency-adul":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100650762","a-study-on-the-efficacy-of-different-doses-of-oryz-aspergillus-enzyme-and-pancreatin-tablet-in-treating-pancreatic-exocrine-insufficiency-after-gastrointestinal-surgery-100650762",false,"NCT07751367","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","Inclusion Criteria:\n\n* Age between 18 and 75 years (inclusive of boundary values), regardless of gender;\n* History of prior gastrointestinal surgical treatment, including but not limited to:\n\nI. 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);\n\n* 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;\n* Diagnosis of pancreatic exocrine insufficiency (PEI) based on comprehensive assessment by the investigator considering medical history, symptoms, nutritional status, and pancreatic function;\n* Gastrointestinal Quality of Life Index (GIQLI) score ≤ 105 points;\n* Stable postoperative condition without systemic infection, anastomotic leak, or other severe postoperative complications;\n* Participants fully understand the study and voluntarily sign a written informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n* Known allergy to any component of micafungin pancreatic enzyme tablets;\n* Patients with acute pancreatitis or acute exacerbation during active phase of chronic pancreatitis, or those with known contraindications listed in the product label;\n* Patients with rare inherited fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency\n* Gastrointestinal obstruction;\n* Use of other digestive enzyme replacement therapies during the study period;\n* 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;\n* 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\u002Fradiotherapy\u002Ftargeted therapy or other systemic anti-tumor treatments prior to or during surgery, even if the primary tumor was staged as Stage I or II;\n* Post-gastrointestinal surgery patients diagnosed clinically with gastroparesis, or meeting any of the following criteria for diagnosing delayed gastric emptying (DGE):\n\nI.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;\n\n* Currently participating in another clinical trial, or recently completed another clinical trial without having reached the required washout period (within 28 days);\n* Other patients judged by the investigator as unsuitable for participation in this clinical trial.","ALL","18 Years","75 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"Pancreatic Exocrine Insufficiency, Adul","NOT_YET_RECRUITING","2026-08-06",{"date":31,"type":32},"2026-08-07","ACTUAL",{"date":34,"type":21},"2026-09-18",{"date":36,"type":21},"2028-12-31",{"name":38,"class":39},"Tianjin Medical University Cancer Institute and Hospital","OTHER"]