Clinical trial · Interventional
Pancreatic Resection, Malnutrition and Readmission
Pancreatic Resection, Malnutrition, and Readmission: Assessment and Prevention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malnutrition | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nestle Impact Advanced Recovery nutritional supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple as measured by percentage of adherence to nutritional protocol
- timeFrame
- Up to week 6
- description
- 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.
- measure
- Readmission Rate
- timeFrame
- Up to week 6
- description
- Evaluate the impact of a standard perioperative nutritional plan on primary outcome of readmission rate.
Secondary outcomes (4)
- measure
- Readmission cause
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available