The Effect of PERT on Patients Undergoing Pancreaticoduodenectomy

November 1, 2023 updated by: Weishen WANG, Ruijin Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PERT Group
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
pancreatic enzyme replacement therapy
Placebo Comparator: Placebo Group
Follow the routine treatment plan for pancreatic tumors during the perioperative period.
Other: Routine treatment plan
Routine treatment plan without PERT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal Skeletal Muscle Index (SMI)
Time Frame: 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.
8 weeks post-operation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBP-RCT-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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