Resting Energy Expenditure, Nutritional Intake, and Postoperative Outcomes in Patients Undergoing Total or Partial Pancreatectomy for Pancreatic Tumors: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Pancreatectomy (Procedure)
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.
干预措施: Indirect calorimetry (Diagnostic Test)
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.
干预措施: Pancreatectomy (Procedure)
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.
干预措施: Indirect calorimetry (Diagnostic Test)
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.
干预措施: Pancreatectomy (Procedure)
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.
干预措施: Indirect calorimetry (Diagnostic Test)
结局指标
主要结局
Length of Hospital Stay
时间窗: From surgery through hospital discharge (up to approximately 30 days).
Total duration of the index hospitalization, in days.
次要结局
- 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.)
- Protein Intake as Percentage of Requirements(Postoperative days 2, 4, and 8, and up to 30 days (hospital discharge))
研究者
Dimitrios Karayiannis
Director, Department of Clinical Nutrition
Evangelismos Hospital
