Pancreatic Resection, Malnutrition and Readmission

Pancreatic Cancer Clinical Trial

Official title:

Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947166
• Other study ID #: Pro00047214
• Status: Completed
• Phase: N/A
• First received: August 23, 2013
• Last updated: November 28, 2016
• Start date: December 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Dietary Supplement:
• Nestle Impact Advanced Recovery nutritional supplement
Before Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days (15 servings total) on postoperative day minus 5 through postoperative day 1 in addition to normal diet. After Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days on postoperative day 2 through postoperative day 6.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol	Evaluate the feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple by outcomes of: 1)admission rates, 2) admission causes 3)percentage of adherence to nutritional protocol 4) length of stay 5) reported symptoms (nausea, vomiting, diarrhea), 6) postsurgical complications 7) nutritional status preoperative visit between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6.	Up to week 6	No
Primary	Readmission Rate	Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.	Up to week 6	No
Secondary	Readmission cause	Evaluate the impact of a standard perioperative nutritional plan on readmission cause.	Up to week 6	No
Secondary	Length of stay for initial hospitalization and/or readmission	Evaluate the impact of a standard perioperative nutritional plan on length of stay for initial hospitalization and/or readmission.	Up to week 6	No
Secondary	Post surgical complications	Evaluate the impact of a standard perioperative nutritional plan on post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying) between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6.	Up to week 6	No
Secondary	Nutritional status	Evaluate the impact of a standard perioperative nutritional plan on nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake) at preoperative visit, between days 2 - 5 postoperatively, on the day of discharge, and at follow up visits at weeks 1, 3 and 6	Up to week 6	No