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Resting Energy Expenditure, Nutritional Intake, and Postoperative Outcomes in Patients Undergoing Total or Partial Pancreatectomy for Pancreatic Tumors: A Prospective Observational Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Greece
Evaggelismos General Hospital
RECRUITING
Athens
Contact Information
Primary
Dimitrios Karagiannis, PhD
jimkar_d@yahoo.com
2132045035
Backup
Ζοι Bouloubassi, MSc
zoippp@yahoo.com
2132041685
Time Frame
Start Date: 2017-01-10
Estimated Completion Date: 2028-11-10
Participants
Target number of participants: 150
Treatments
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.
Sponsors
Collaborators: University of Peloponnese, Agricultural University of Athens
Leads: Evangelismos Hospital

This content was sourced from clinicaltrials.gov