Whipple Protein Study (WPS)

March 2, 2023 updated by: Thomas Jefferson University

High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy

Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pancreaticoduodenectomy (PD) is a complex and morbid operation that is associated with many potential complications. Many people undergoing PD are malnourished due to their underlying medical condition or difficulties eating in the face of abdominal pain or obstruction from pancreatic disease. This study aims to assess the effect of high-protein dietary supplementation in improving perioperative nutrition and decreasing complications. We will randomize PD patients to an experimental arm in which they take a nutritional, high-protein supplement for 2 weeks before and after surgery, or to a control arm, where they will take a standard postoperative diet without supplementation. Outcomes and nutritional parameters will be examined after they complete the supplements.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing pancreaticoduodenectomy
  • Patients aged 18 years and older
  • Patients able to provide written informed consent
  • Patients able to understand and comply with study guidelines
  • Patients able to tolerate oral intake
  • Patients who are malnourished or at risk of malnutrition as defined by a score less than 12 on the Mini-Nutritional Assessment

Exclusion Criteria:

  • Patients with a milk protein allergy
  • Patients with a vegan diet
  • Patients dependent on artificial enteral feeding
  • Patients with end-stage renal disease undergoing dialysis
  • Patients who are pregnant
  • Patients with ongoing eating disorder or condition precluding oral intake
  • Patients who are scheduled for pancreaticoduodenectomy but are unable to receive this surgery

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Protein Supplement
60 g total protein per day, administered via twice daily ensure max protein shakes
Dietary supplement: Ensure Max Protein
Liquid shake with 30 g protein per serving
No Intervention: Control
No intervention on diet; routine dietary practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 30 days
All complications within 30 days of surgery
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 6 months
Overall survival time since surgery
6 months
Prealbumin level
Time Frame: 30 days
Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition.
30 days

Collaborators and Investigators

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

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Harish Lavu, MD, Associate Professor

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 (Actual)

August 20, 2019

Primary Completion (Actual)

May 10, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19D.669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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