Pancreatic Enzyme Replacement Therapy, Pancreatic Exocrine Insufficiency, Pancreaticoduodenectomy
Conditions
Brief 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.
Interventions
pancreatic enzyme replacement therapy
OTHERRoutine treatment plan
Routine treatment plan without PERT
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal Skeletal Muscle Index (SMI) | 8 weeks post-operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 8 weeks post-operation | postoperative pancreatic fistula, delayed gastric emptying, postoperative hypoproteinemia; |
| Nutritional indicators | 8 weeks post-operation | Patient generated subjective global assessment (PG-SGA); |
Countries
China
Contacts
Primary ContactWeishen WANG, DR
Outcome results
None listed