The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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: The effect of PERT on postoperative complications and physiological status after pancreaticoduodenectomy; The efficacy of PERT treatment on clinical symptoms, nutritional indicators, and quality of life (QOL) related to pancreatic exocrine dysfunction (PEI) after pancreaticoduodenectomy; The personalized full process nutrition management strategies based on risk factor stratification.

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

Conditions
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Pancreatic Exocrine Insufficiency, Pancreatic Enzyme Replacement Therapy, Pancreaticoduodenectomy

Intervention / Treatment
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* Drug: Pancreatin Enteric-coated Capsules
* Other: Routine treatment plan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PERT Group<br>After surgery, resume diet and begin receiving standard PERT treatment (2 capsules per meal, 1 capsule per snack, taken with meals, starting at a dose of 40000 to 50000 units of lipase) for 8 weeks. | Drug: Pancreatin Enteric-coated Capsules<br>* pancreatic enzyme replacement therapy<br>|
| Placebo Comparator: Placebo Group<br>Follow the routine treatment plan for pancreatic tumors during the perioperative period. | Other: Routine treatment plan<br>* Routine treatment plan without PERT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | postoperative pancreatic fistula, delayed gastric emptying, postoperative hypoproteinemia; | 8 weeks post-operation | 
| Nutritional indicators | Patient generated subjective global assessment (PG-SGA); | 8 weeks post-operation |