The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

Phase 4

Recruiting

• Conditions: Pancreatic Exocrine Insufficiency; Pancreaticoduodenectomy; Pancreatic Enzyme Replacement Therapy
• Interventions: Drug: Pancreatin Enteric-coated Capsules; Other: Routine treatment plan

• Registration Number: NCT06119880
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-25
• Status Verified: 2023-11
• Study Start: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PERT Group	Pancreatin Enteric-coated Capsules	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.
Placebo Group	Routine treatment plan	Follow the routine treatment plan for pancreatic tumors during the perioperative period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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);

Trial Locations

Locations (1)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China