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The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

NCT06119880 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-07

No results posted yet for this study

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

DRUG

Pancreatin Enteric-coated Capsules

pancreatic enzyme replacement therapy

OTHER

Routine treatment plan

Routine treatment plan without PERT

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06119880 on ClinicalTrials.gov