The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119880
• Other study ID #: HBP-RCT-004
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: Weishen WANG, DR
• Phone: 64370045
• Email: peanutswey[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Exocrine Insufficiency
• Pancreaticoduodenectomy

Intervention

Drug:
• Pancreatin Enteric-coated Capsules
pancreatic enzyme replacement therapy

Other:
• Routine treatment plan
Routine treatment plan without PERT

Locations

Country	Name	City	State
China	Shanghai Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

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