Whipple Protein Study

Thomas Jefferson University22 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer Malnutrition

Interventions

Ensure Max ProteinDIETARY_SUPPLEMENT

Liquid shake with 30 g protein per serving

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Complications

All complications within 30 days of surgery

Time frame: 30 days

Secondary Outcomes

Overall Survival

Overall survival time since surgery

Time frame: 6 months

Prealbumin level

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

Time frame: 30 days

Data from ClinicalTrials.gov

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