Whipple Protein Study

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

Detailed Description
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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.

Official Title
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High-Protein Oral Nutritional Supplementation in Patients Undergoing Pancreaticoduodenectomy

Conditions
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Pancreatic Cancer, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Ensure Max Protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Protein Supplement<br>60 g total protein per day, administered via twice daily ensure max protein shakes | Dietary Supplement: Ensure Max Protein<br>* Liquid shake with 30 g protein per serving<br>|
| No Intervention: Control<br>No intervention on diet; routine dietary practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | All complications within 30 days of surgery | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, surgery, nutrition, protein