Whipple Protein Study

NCT ID: NCT04306874

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2022-11-15

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.

Conditions

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Pancreatic Cancer Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel, non-blinded, randomized controlled two-arm trial: supplement vs. placebo
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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High Protein Supplement

60 g total protein per day, administered via twice daily ensure max protein shakes

Group Type EXPERIMENTAL

Ensure Max Protein

Intervention Type DIETARY_SUPPLEMENT

Liquid shake with 30 g protein per serving

Control

No intervention on diet; routine dietary practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ensure Max Protein

Liquid shake with 30 g protein per serving

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harish Lavu, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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JT 14375

Identifier Type: OTHER

Identifier Source: secondary_id

19D.669

Identifier Type: -

Identifier Source: org_study_id

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