Pancreatic Resection, Malnutrition and Readmission

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01947166
First received: August 23, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Pancreatic Cancer
Malnutrition
Dietary Supplement: Nestle Impact Advanced Recovery nutritional supplement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol [ Time Frame: Up to week 6 ] [ Designated as safety issue: No ]
    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.

  • Readmission Rate [ Time Frame: Up to week 6 ] [ Designated as safety issue: No ]
    Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.


Secondary Outcome Measures:
  • Readmission cause [ Time Frame: Up to week 6 ] [ Designated as safety issue: No ]
    Evaluate the impact of a standard perioperative nutritional plan on readmission cause.

  • Length of stay for initial hospitalization and/or readmission [ Time Frame: Up to week 6 ] [ Designated as safety issue: No ]
    Evaluate the impact of a standard perioperative nutritional plan on length of stay for initial hospitalization and/or readmission.

  • Post surgical complications [ Time Frame: Up to week 6 ] [ Designated as safety issue: No ]
    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.

  • Nutritional status [ Time Frame: Up to week 6 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947166

Contacts
Contact: Kara L Penne, RN, MSN, ANP 919-681-7348 kara.penne@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Kara L Penne, RN,MSN,ANP, AOCNP    919-681-7348    kara.penne@duke.edu   
Principal Investigator: Kara L Penne, RN, MSN, ANP, AOCNP         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Kara L Penne, RN, MSN, ANP Duke University Health System
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01947166     History of Changes
Other Study ID Numbers: Pro00047214
Study First Received: August 23, 2013
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Whipple

Additional relevant MeSH terms:
Pancreatic Neoplasms
Malnutrition
Nutrition Disorders
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 11, 2014