NCT06119880

The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

The Effect of PERT on Postoperative Complications and Physiological Status in Patients Undergoing Pancreaticoduodenectomy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A comprehensive perioperative nutrition management plan for pancreaticoduodenectomy, primarily based on pancreatic enzyme replacement therapy (PERT). A prospective randomized controlled study was conducted to comprehensively analyze the perioperative nutritional status of patients undergoing pancreaticoduodenectomy, with the aim of exploring: 1. The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy; 2. The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy; 3. The personalized full process nutrition management strategies based on risk factor stratification.

Conditions

• Pancreatic Exocrine Insufficiency
• Pancreatic Enzyme Replacement Therapy
• Pancreaticoduodenectomy

Interventions

Type	Name	Description
DRUG	Pancreatin Enteric-coated Capsules	pancreatic enzyme replacement therapy
OTHER	Routine treatment plan	Routine treatment plan without PERT

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: China