Energy Expenditure and Nutrition After Pancreatic Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorEvangelismos Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pancreatectomy
Procedure/SurgeryTotal 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.
Indirect calorimetry
Diagnostic testMeasurement 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.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Enteral and oral nutrition2 interventions
Group B: Parenteral nutrition2 interventions
Group C: Combined enteral and parenteral nutrition2 interventions
Trial outcomes
Primary outcomes
1
Length of Hospital Stay
Total duration of the index hospitalization, in days.
Time frame
From surgery through hospital discharge (up to approximately 30 days).Secondary outcomes
1
Agreement Between Measured and Predicted Resting Energy Expenditure
Agreement between mREE and each estimation method (Harris-Benedict, Schofield, 25 kcal/kg, 30 kcal/kg), assessed by Bland-Altman mean bias and 95% limits of agreement, mean absolute percentage error (MAPE), and root mean square error (RMSE). Equations are compared with raw mREE; weight-based targets with activity-adjusted mREE × 1.15.
Time frame
Within 14 days after surgery.2
Measured Resting Energy Expenditure (mREE)
Resting energy expenditure measured by indirect calorimetry (Cosmed Q-NRG+) and derived using the abbreviated Weir equation, expressed in kcal/day.
Time frame
Within 14 days after surgery.3
. Energy Intake as Percentage of Requirements
Daily energy delivery as a percentage of individually calculated energy requirements, reported overall and by feeding-route group (enteral+oral, parenteral only, combined). Unit of Measure: Percentage of estimated requirements (%)
Time frame
Postoperative days 2, 4, and 8, and up to 30 days (hospital discharge)4
Incidence of Postoperative Complications
Proportion of participants with delayed gastric emptying, postoperative pancreatic fistula, or infectious complications, recorded per standard clinical definitions.
Time frame
From surgery through 90 days postoperatively.Sponsors and contacts
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Evangelismos Hospital
Lead sponsor
University of Peloponnese
Collaborator
Agricultural University of Athens
Collaborator
Source ClinicalTrials.gov