[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650762":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":51,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Tianjin Medical University Cancer Institute and Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-dose group","ACTIVE_COMPARATOR","Oryz-Aspergillus Enzyme And Pancreatin Tablet",[13],"Drug: High-dose group: Oryz-Aspergillus Enzyme and Pancreatin Tablet",{"label":15,"type":16,"description":11,"interventionNames":17},"Low-dose group","EXPERIMENTAL",[18],"Drug: Low-dose group: Oryz-Aspergillus Enzyme And Pancreatin Tablet",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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);",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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).",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Jihui Hao M.D.","CONTACT","022-23524155","ec_tjcih@126.com",[37],{"facility":5,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Tianjin","Tianjin Municipality","300000","China","CN",{"type":44,"coordinates":45},"Point",[46,47],117.17667,39.14222,{"lat":47,"lon":46},[50],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71],"Pancreatic Exocrine Insufficiency, Adul","NOT_YET_RECRUITING","2026-08-06",{"date":75,"type":76},"2026-08-07","ACTUAL",{"date":78,"type":65},"2026-09-18",{"date":80,"type":65},"2028-12-31",{"name":5,"class":6},1]