Whipple Protein Study

Overview

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

Full Title of Study: “High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2021

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.

Interventions

  • Dietary Supplement: Ensure Max Protein
    • Liquid shake with 30 g protein per serving

Arms, Groups and Cohorts

  • Experimental: High Protein Supplement
    • 60 g total protein per day, administered via twice daily ensure max protein shakes
  • No Intervention: Control
    • No intervention on diet; routine dietary practice

Clinical Trial Outcome Measures

Primary Measures

  • Complications
    • Time Frame: 30 days
    • All complications within 30 days of surgery

Secondary Measures

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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Thomas Jefferson University
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Harish Lavu, MD, Principal Investigator, Associate Professor
    • Overall Contact(s)
      • Richard Zheng, MD, 6464278188, Rzheng4@gmail.com

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