Energy Expenditure and Nutrition After Pancreatic Surgery
NUTRI-PD
Resting Energy Expenditure, Nutritional Intake, and Postoperative Outcomes in Patients Undergoing Total or Partial Pancreatectomy for Pancreatic Tumors: A Prospective Observational Cohort Study
1 other identifier
observational
150
1 country
1
Brief Summary
This prospective observational cohort study examines the energy requirements and nutritional care of patients undergoing total or partial pancreatectomy for pancreatic tumors. Patients undergoing pancreatectomy face major metabolic stress, a high burden of preoperative malnutrition, and frequent exocrine or endocrine insufficiency, yet procedure-specific nutritional guidance is limited. The study measures resting energy expenditure (REE) directly by indirect calorimetry during the early postoperative period and compares it with widely used predictive equations (Harris-Benedict, Schofield) and simplified weight-based targets (25 and 30 kcal/kg) to determine how accurately clinicians can estimate energy needs when calorimetry is unavailable. In the same patients, the study records the route of postoperative nutrition (enteral, parenteral, or combined), energy and protein intake relative to requirements, and diet-related symptoms, and follows postoperative complications, hospital readmission, mortality, and changes in body weight and body mass index through 3-6 months after surgery. By capturing measured energy expenditure and nutritional delivery in one cohort, the study aims to clarify whether adequacy of energy and protein intake, feeding route, or both influence recovery, and to provide primary data for developing individualized nutritional support protocols in this high-risk surgical population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
January 10, 2017
CompletedFirst Submitted
Initial submission to the registry
July 4, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 10, 2028
July 14, 2026
July 1, 2026
11 years
July 4, 2026
July 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of Hospital Stay
Total duration of the index hospitalization, in days.
From surgery through hospital discharge (up to approximately 30 days).
Secondary Outcomes (6)
Agreement Between Measured and Predicted Resting Energy Expenditure
Within 14 days after surgery.
Measured Resting Energy Expenditure (mREE)
Within 14 days after surgery.
. Energy Intake as Percentage of Requirements
Postoperative days 2, 4, and 8, and up to 30 days (hospital discharge)
Incidence of Postoperative Complications
From surgery through 90 days postoperatively.
All-Cause Mortality
At 30, 90, and 180 days after surgery.
- +1 more secondary outcomes
Study Arms (3)
Enteral and oral nutrition
Participants undergoing total or partial pancreatectomy for a pancreatic tumor whose postoperative nutrition is delivered by the enteral route together with oral intake. Feeding route is not assigned by the study; it is determined by the treating surgical and nutrition support teams according to clinical status and tolerance, and recorded as an observed exposure. All participants in this cohort undergo indirect calorimetry and structured documentation of energy and protein intake during the early postoperative period.
Parenteral nutrition
Participants undergoing total or partial pancreatectomy for a pancreatic tumor whose postoperative nutrition is delivered exclusively by the parenteral route, as determined clinically by the treating teams. As in the other cohorts, participants undergo indirect calorimetry and documentation of nutritional delivery, complications, and follow-up outcomes.
Combined enteral and parenteral nutrition
Participants undergoing total or partial pancreatectomy for a pancreatic tumor who receive combined enteral and parenteral nutrition, as determined clinically by the treating teams. Participants undergo the same calorimetry, intake documentation, and follow-up assessments as the other cohorts.
Interventions
Total or partial pancreatectomy (including pancreaticoduodenectomy / Whipple procedure and distal pancreatectomy) performed for a pancreatic tumor. This is the qualifying surgical exposure common to all participants. Applies to: Cohort 1, Cohort 2, Cohort 3.
Measurement of resting energy expenditure by indirect calorimetry (Cosmed Q-NRG+), performed under standardized fasting and steady-state conditions during the early postoperative period. This is the reference measurement against which predictive equations and weight-based targets are compared.
Eligibility Criteria
Consecutive adult patients admitted for total or partial pancreatectomy - including pancreaticoduodenectomy (Whipple procedure) and distal pancreatectomy - for a pancreatic tumor at the participating surgical center. The cohort reflects the real-world case mix referred for pancreatic resection and therefore includes both malignant tumors and premalignant or benign lesions (such as intraductal papillary mucinous neoplasm and ampullary tumors), spanning the head, body, and tail of the pancreas. Participants are enrolled preoperatively and followed through the early postoperative period and to 3-6 months after discharge. Within this single cohort, the postoperative feeding route (enteral with oral intake, parenteral, or combined) is observed rather than assigned and is analyzed as an exposure of interest.
You may qualify if:
- Age 18 years or older
- Scheduled to undergo total or partial pancreatectomy (including pancreaticoduodenectomy/Whipple procedure or distal pancreatectomy) for a pancreatic tumor
- Able to complete indirect calorimetry measurement by canopy or face mask for the required duration
- Able to provide written informed consent
You may not qualify if:
- Age under 18 years, greater than 75 years
- Pregnancy
- Inability to tolerate the calorimetry canopy or mask for the duration required for a valid measurement
- Unable or unwilling to provide informed consent
- patients already on preoperative enteral nutrition or unable to feed orally preoperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Evangelismos Hospitallead
- Agricultural University of Athenscollaborator
- University of Peloponnesecollaborator
Study Sites (1)
Evaggelismos General Hospital
Athens, Attica, 10676, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kalliopi Anna Poulia, PhD
School of Food and Nutritional Sciences, Agricultural University of Athens
- STUDY CHAIR
Melina Dimitriou, PhD
m.dimitriou@go.uop.gr
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Department of Clinical Nutrition
Study Record Dates
First Submitted
July 4, 2026
First Posted
July 14, 2026
Study Start
January 10, 2017
Primary Completion (Estimated)
January 10, 2028
Study Completion (Estimated)
November 10, 2028
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 6 months after publication of the primary results and ending 36 months after publication.
- Access Criteria
- Access is granted to qualified researchers who submit a written request with a scientifically justified proposal to the corresponding author. Requests are evaluated by the sponsor/institution and require ethics-committee approval and execution of a data-access/data-transfer agreement before any data are released. Data are provided in de-identified form for the approved analysis only and may not be redistributed.
De-identified individual participant data underlying published results will be made available to qualified researchers whose proposed use has been approved by an independent review committee. Requests must include a methodologically sound proposal and a signed data-access agreement, and data will be shared only after the necessary approvals from the sponsoring institution and the ethics committee, and only to the extent permitted by the participants' informed consent and applicable data-protection law (including the EU General Data Protection Regulation). Given the single-center design and limited sample size, data will be released in de-identified form with any potentially identifying variables removed or aggregated to minimize re-identification risk.