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Efficacy and safety of pancreatic enzyme replacement therapy in acute pancreatitis associated with severe pancreatic exocrine insufficiency: a single-center, randomized controlled trial

Efficacy and safety of pancreatic enzyme replacement therapy in acute pancreatitis associated with severe pancreatic exocrine insufficiency: a single-center, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088273
Enrollment
Unknown
Registered
2024-08-14
Start date
2024-08-31
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pancreatitis

Interventions

Pancreatic enzyme replacement treatment group:Pancretic enzyme enteric capsules each time, three times a day, the whole tablet during eating or enteral nutrition, or added to the nutrient solution
control group:NA

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18~85 years old; 2.MSAP and SAP patients who meet the diagnostic criteria for AP; 3.FE-1 was diagnosed as a severe PEI

Exclusion criteria

Exclusion criteria: 1.Remitted due to AP complications; 2.Other possible causes of EPI include chronic pancreatitis, celiac disease, diabetic gastroparesis, cystic fibrosis, pancreatic tumors, etc.; 3.Hyperthyroidism; 4.Previous gastrointestinal or pancreatic surgery; 5.Gastrointestinal outflow tract obstruction or mechanical intestinal obstruction; 6.Intraabdominal pressure is above 15mmHg; 7.Pregnant or lactating women; 8.Refused to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Incidence of nutritional intolerance in enteral nutrition in patients 3-7 days after the first dose;

Secondary

MeasureTime frame
Relief rate of nutritional intolerance symptoms (abdominal distension, etc.) after 24 hours of pancr;Change in clinical symptoms:Defmovement frequency, stool characteristics,;blood albumin;weight;BMI;SF-36 Quality of life survey form;

Countries

China

Contacts

Public ContactHe Wenhua

The First Affiliated Hospital of Nanchang University

hewenhua@ncu.edu.cn+86 138 7918 2642

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026