Whipple Protein Study

Not Applicable

Completed

• Conditions: Malnutrition; Pancreatic Cancer
• Interventions: Dietary Supplement: Ensure Max Protein

• Registration Number: NCT04306874
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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

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 Timeline

• Study Start: 2019-08-20
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2020-03-10
• Study First Posted: 2020-03-13
• Primary Completion: 2022-05-10
• Study Completion: 2022-11-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Protein Supplement	Ensure Max Protein	60 g total protein per day, administered via twice daily ensure max protein shakes

Primary Outcome Measures

Name	Time	Method
Complications	30 days	All complications within 30 days of surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States