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Pancreatic Resection, Malnutrition and Readmission

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Duke University

Status

Completed

Conditions

Malnutrition
Pancreatic Cancer

Treatments

Dietary Supplement: Nestle Impact Advanced Recovery nutritional supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT01947166
Pro00047214

Details and patient eligibility

About

The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients (>18 years of age)at Duke Cancer Center
  • Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple)
  • Able to read and speak English.

Exclusion criteria

  • Patients receiving preoperative enteral nutrition
  • Inability to tolerate preoperative oral intake

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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