Pancreatic Resection, Malnutrition and Readmission

Completed · Not applicable

Conditions studied: Pancreatic Cancer, Malnutrition

In brief

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.

Key facts

Study ID

NCT01947166

Run by

Duke University

People needed

38

Starts

2013-12-01

Expected to finish

2016-06-01

Last updated by the study team

2016-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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