Pancreaticoduodenectomy Clinical Trial
Official title:
The Effect of PERT on Postoperative Complications and Physiological Status in Patients Undergoing Pancreaticoduodenectomy
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Gender unlimited, 18-80 years old; - Patients undergoing pancreaticoduodenectomy due to various benign or malignant diseases; - Voluntary testing with informed consent. Exclusion Criteria: - Pregnant women and lactating women - Patients with distant metastasis based on tumor staging before surgery; - Tumor recurrence; - Refuse to sign the consent form. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Ruijin Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abdominal Skeletal Muscle Index (SMI) | Measurement of abdominal skeletal muscle area at the third lumbar spine plane using abdominal plain scan CT and comparison of baseline level SMI change rate. | 8 weeks post-operation | |
Secondary | Postoperative complications | postoperative pancreatic fistula, delayed gastric emptying, postoperative hypoproteinemia; | 8 weeks post-operation | |
Secondary | Nutritional indicators | Patient generated subjective global assessment (PG-SGA); | 8 weeks post-operation |
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