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Whipple ProceduresNUTRI-PDNCT07703813

Energy Expenditure and Nutrition After Pancreatic Surgery

An observational study of Whipple Procedures and Pancreatic Cancer, run by Evangelismos Hospital at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pancreatectomy and Indirect calorimetry
How many people
150 participants
Where
1 siteGreece
Study dates
10 Jan 2017to 10 Nov 2028
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dimitrios Karagiannis, PhD contact

2132045035 ext. +30

jimkar_d@yahoo.com

Ζοι Bouloubassi, MSc contact

2132041685 ext. +30

zoippp@yahoo.com

Greece1 site, 1 recruiting
  • Evaggelismos General Hospital

    Athens, Attica, 10676

    Dimitrios Karagiannis, 6937158640, jimkar_d@yahoo.com

    Recruiting

Other trials in Greece

About this study

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

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.

Read the detailed description

Background and Rationale Patients undergoing pancreatic resection experience surgical stress, systemic inflammation, and frequent exocrine and endocrine insufficiency that together alter energy metabolism and place them at high risk of nutritional deterioration. Predictive equations and simplified weight-based targets are used routinely to prescribe nutrition when indirect calorimetry is unavailable, but their accuracy in this specific surgical population is poorly characterized, and the degree to which the route and adequacy of postoperative feeding influence recovery has not been examined alongside directly measured energy expenditure in the same patients. This study is designed to address both questions within a single prospective cohort, pairing calorimetry-based measurement of resting energy expenditure with structured documentation of nutritional delivery and clinical outcomes.

Design and Setting The study is a single-center prospective observational cohort study. Consecutive eligible adults undergoing total or partial pancreatectomy for pancreatic tumors are enrolled preoperatively after informed consent. Feeding route is not assigned by the protocol; it is determined case by case by the treating surgical and nutrition support teams according to clinical status and tolerance, and is recorded as an observed exposure. All measurements and data abstraction are performed by trained clinical dietitians and drawn from direct measurement and the medical record.

Indirect Calorimetry Procedure Measured resting energy expenditure (mREE) is determined using a Cosmed Q-NRG+ portable indirect calorimeter. The device is calibrated before each session per the manufacturer's automatic gas-calibration procedure. Measurements are obtained by canopy where feasible, with a face mask used only when a canopy cannot be applied, recording VO₂ and VCO₂. Patients are measured supine, awake, and motionless in the morning after an 8-10 hour fast, at a controlled room temperature of 22-24 °C, following a minimum 20-30 minutes of rest. The first five minutes of each recording are discarded, and steady state is defined as at least five consecutive minutes during which the coefficient of variation in VO₂ and VCO₂ does not exceed 10%. Caffeine and strenuous activity are avoided for at least 12 hours beforehand, and supplemental oxygen is suspended or accounted for where clinically feasible. mREE is derived using the abbreviated Weir equation, mREE = (3.94 × VO₂ + 1.11 × VCO₂) × 1.44, and the respiratory quotient is calculated as VCO₂/VO₂. To reduce the influence of single-timepoint sampling within a dynamic postoperative course, calorimetry is scheduled at more than one time point during the early recovery period where the patient's clinical stability permits, with the exact days recorded.

Estimation of Energy Requirements for Comparison Predicted resting energy expenditure is calculated for each patient using the Harris-Benedict and Schofield equations. Harris-Benedict is applied as: men, 66.47 + 13.75 × weight (kg) + 5.0 × height (cm) - 6.75 × age; women, 665.09 + 9.56 × weight (kg) + 1.84 × height (cm) - 4.67 × age. Schofield is applied by sex and age band. For overweight patients, ideal body weight is used in these equations; for obese patients, corrected weight [ideal body weight + 0.25 × (actual - ideal body weight)] is used. Total energy requirements are additionally estimated from the ESPEN weight-based targets of 25 and 30 kcal/kg of ideal body weight (adjusted using a BMI of 22 kg/m² for overweight and 24.9 kg/m² for obese patients) and compared with mREE adjusted by an activity/stress factor of 1.15. Because the two families of estimates target different quantities - basal/resting expenditure for the equations versus total requirements for the weight-based targets - equation comparisons use raw mREE while weight-based comparisons use mREE × 1.15, and this distinction is retained throughout analysis.

Nutritional Intake and Feeding-Route Documentation For each patient, the route of postoperative nutrition (enteral plus oral, parenteral only, or combined enteral and parenteral) is recorded, together with the formulation used, the daily administered volume, and the delivery rate. Daily energy and protein delivery are quantified and expressed relative to individually calculated requirements to derive an energy deficit and a protein deficit for the early postoperative period. Diet-related symptoms (including diarrhea and abdominal pain) are recorded prospectively. These data support the planned subgroup comparison of outcomes across feeding routes and across strata of energy and protein deficit.

Anthropometry and Body Composition Body weight is measured on a calibrated electronic scale to the nearest 0.1 kg. Height is measured with the patient standing upright, unshod and bare-headed, using the Frankfort horizontal plane for head alignment. BMI is calculated as weight (kg) divided by height squared (m²). Weight and BMI are recorded at the preoperative assessment, at discharge, and at the 3-6 month follow-up, and recent percentage weight change is documented. Because body weight in the early postoperative period is confounded by fluid shifts, third-spacing, and edema, preoperative weight is used as the reference exposure in modeling, and objective body composition assessment (bioelectrical impedance or CT-derived skeletal muscle measurement, where available) is incorporated to distinguish loss of fat mass from loss of lean mass.

Nutritional Risk Screening and Biochemical Markers Preoperative nutritional risk is screened using the Perioperative Nutrition Screen (PONS), which weights recent weight loss, reduced intake or anorexia, low BMI, and the presence of a high-metabolic-risk underlying disease. Serum albumin (as a surrogate marker of visceral protein status) and C-reactive protein (as a marker of systemic inflammation) are recorded as exploratory variables at defined time points around the calorimetry measurement, per the hospital's standard laboratory procedures. Clinical variables including comorbidities, tumor site and surgical procedure, postoperative complications, length of stay, and readmissions are abstracted from the medical record.

Follow-up Schedule Assessments are anchored to the perioperative pathway: a preoperative baseline (anthropometry, screening, biochemistry), early postoperative calorimetry and intake documentation during the index admission, a discharge assessment, and a follow-up contact at 3-6 months after discharge for anthropometry and outcome ascertainment. Complication, readmission, and mortality windows follow the postoperative course as specified in the outcome measures.

Statistical Analysis Plan Analyses will be conducted in Jamovi with two-tailed tests at α = 0.05. Distributional normality is assessed by the Shapiro-Wilk test; normally distributed continuous variables are summarized as mean (SD) and non-normal variables as median (interquartile range), with categorical variables as counts and percentages. Agreement between mREE and each estimation method is evaluated by Bland-Altman analysis, reporting mean bias, 95% limits of agreement, and tests for proportional bias, complemented by accuracy indices (percentage within ±10% and ±20%, mean absolute percentage error, and root mean square error) and by linear regression of estimates against mREE. Determinants of mREE are examined using multiple linear regression with prespecified adjustment sets (unadjusted; age and sex; and additionally CRP and albumin). Changes in weight, BMI, and laboratory markers across time points are analyzed with repeated-measures ANOVA or Friedman's test as appropriate, with pairwise comparisons. Where repeated calorimetry measurements are obtained, longitudinal trajectories are analyzed using linear mixed-effects models to accommodate within-patient correlation and variable measurement timing. Feeding route and deficit strata are compared for complications, readmission, and mortality. The single-center design and anticipated sample size are recognized as constraints on power and generalizability, and subgroup analyses (including by surgical type) are treated as exploratory.

Being tested
Pancreatectomy, Indirect calorimetry
Keywords
Nutrition, Nutrition support, Indirect calorimetry, Pancreaticoduodenectomy, Surgical oncology nutrition, Postoperative nutrition
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PancreatectomyProcedure or surgery

    Also called Indirect calorimetry

    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.

  • Indirect calorimetryDiagnostic test

    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.

Study groups in NCT07703813
Study groupRoleWhat they receive
Enteral and oral nutritionParticipants 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.
Receives: Procedure: Pancreatectomy; Diagnostic Test: Indirect calorimetry
Parenteral nutritionParticipants 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.
Receives: Procedure: Pancreatectomy; Diagnostic Test: Indirect calorimetry
Combined enteral and parenteral nutritionParticipants 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.
Receives: Procedure: Pancreatectomy; Diagnostic Test: Indirect calorimetry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Length of Hospital Stay

    Total duration of the index hospitalization, in days.

    Measured: From surgery through hospital discharge (up to approximately 30 days).

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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 (%)

    Measured: 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.

    Measured: From surgery through 90 days postoperatively.

  5. All-Cause Mortality

    Proportion of participants who died from any cause.

    Measured: At 30, 90, and 180 days after surgery.

  6. Protein Intake as Percentage of Requirements

    Daily protein delivery as a percentage of individually calculated protein requirements, reported overall and by feeding-route group (enteral+oral, parenteral only, combined).

    Unit of Measure: Percentage of estimated requirements (%)

    Measured: Postoperative days 2, 4, and 8, and up to 30 days (hospital discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start10 Jan 2017
  3. Primary completion10 Jan 2028 (estimated)
  4. Study completion10 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07703813
Sponsor's protocol ID
484/2017
Acronym
NUTRI-PD
Status last verified
Jul 2026
First submitted
4 Jul 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Whipple Procedures and Pancreatic Cancer, run by Evangelismos Hospital at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dimitrios Karagiannis, PhD (2132045035 ext. +30, jimkar_d@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Hospital Stay (time frame: From surgery through hospital discharge (up to approximately 30 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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