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Completed

NCT Number: NCT04306874

Whipple Protein Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ensure Max Protein

Dietary Supplement

Liquid shake with 30 g protein per serving

Primary outcomes

  1. Complications

    Time frame: 30 days

    All complications within 30 days of surgery

Secondary outcomes

  1. Overall Survival

    Time frame: 6 months

    Overall survival time since surgery

  2. Prealbumin level

    Time frame: 30 days

    Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy

Acronym: WPS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2020
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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