NCT01947166

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable pancreatic-cancer

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 29, 2016

Status Verified

November 1, 2016

Enrollment Period

2.5 years

First QC Date

August 23, 2013

Last Update Submit

November 28, 2016

Conditions

Pancreatic CancerMalnutrition

Keywords

Whipple

Outcome Measures

Primary Outcomes (2)

  • 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

  • Readmission Rate

    Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.

    Up to week 6

Secondary Outcomes (4)

  • Readmission cause

    Up to week 6

  • Length of stay for initial hospitalization and/or readmission

    Up to week 6

  • Post surgical complications

    Up to week 6

  • Nutritional status

    Up to week 6

Interventions

Nestle Impact Advanced Recovery nutritional supplementDIETARY_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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsMalnutrition

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Kara L Penne, RN, MSN, ANP

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 20, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 29, 2016

Record last verified: 2016-11

Locations

US(1)