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2019-08-20
2022-05-10
2022-11-15
22
NCT04306874
Thomas Jefferson University
Thomas Jefferson University
INTERVENTIONAL
Whipple Protein Study
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-12-06 | N/A | 2025-05-02 |
2020-03-10 | N/A | 2025-05-07 |
2020-03-13 | N/A | 2025-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: High Protein Supplement 60 g total protein per day, administered via twice daily ensure max protein shakes | DIETARY_SUPPLEMENT: Ensure Max Protein
|
| NO_INTERVENTION: Control No intervention on diet; routine dietary practice |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Complications | All complications within 30 days of surgery | 30 days |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
