Whipple Protein Study
WPS
High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy
2 other identifiers
interventional
22
1 country
1
Brief Summary
Study investigators aim to assess the effect of providing high-protein nutritional supplementation before and after surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pancreatic-cancer
Started Aug 2019
Typical duration for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2019
CompletedFirst Submitted
Initial submission to the registry
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2022
CompletedMay 7, 2025
May 1, 2025
2.7 years
December 6, 2019
May 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complications
All complications within 30 days of surgery
30 days
Secondary Outcomes (2)
Overall Survival
6 months
Prealbumin level
30 days
Study Arms (2)
High Protein Supplement
EXPERIMENTAL60 g total protein per day, administered via twice daily ensure max protein shakes
Control
NO INTERVENTIONNo intervention on diet; routine dietary practice
Interventions
Liquid shake with 30 g protein per serving
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harish Lavu, MD
Associate Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2019
First Posted
March 13, 2020
Study Start
August 20, 2019
Primary Completion
May 10, 2022
Study Completion
November 15, 2022
Last Updated
May 7, 2025
Record last verified: 2025-05