Whipple Protein Study

Pancreatic Cancer Clinical Trial

— WPS  

Official title:

High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306874
• Other study ID #: 19D.669
• Status: Completed
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: November 15, 2022

Study information

• Verified date: March 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 15, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications	All complications within 30 days of surgery	30 days
Secondary	Overall Survival	Overall survival time since surgery	6 months
Secondary	Prealbumin level	Serum prealbumin level (normal 15-36 mg/dL). Lower levels indicate acute malnutrition.	30 days