Clinical and Economic Validation of the International Study Group for Pancreatic Surgery (ISGPS) Definition of Postpancreatectomy Acute Pancreatitis (PPAP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,900
- 试验地点
- 1
- 主要终点
- The difference in length of hospital stay between the PPAP and the non-PPAP group
研究概览
简要总结
This prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment.
详细描述
The study will be conducted at approximately 37 investigative sites in Europe, Asia, Oceania, and the United States. Only high volume centers for Pancreatic Surgery will be included in the study. All patients scheduled to receive elective pancreaticoduodenectomy (PD Kausch-Whipple or Longmire-Traverso) for all type of pancreatic disease (benign, malignant, or premalignant) will be enrolled. The study duration per subject will be up to 30 days after surgery or all the in-hospital lengths of stay. Preoperative care will follow institutional standards, according to each center involved. Surgical resection and reconstruction will be carried out according to the techniques adopted by each participating center. Both patients undergoing open and minimally invasive surgery can be considered eligible. Postoperative management will follow the institutional standards of each center. Serum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days (POD) 1 and 2.Serum C-reactive protein (CRP) will be measured according to each institutional policy and reported once assessed from POD 1 to 3. Drain fluid amylase, or lipase activity will be checked according to the Institutional standards of each involved, and the values will be retrieved whether assessed from POD 1 to five. Radiological imaging will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious for abdominal complications.The severity of complications will be assessed according to the Clavien-Dindo (CD) classification system 32 . Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery. Length of hospital stay is calculated from the day of surgery to discharge. Preoperative, intra-operative, and postoperative data will be recorded prospectively.
The estimated study duration will be 15 months. Time for data analysis must be considered negligible. Patients' follow-up will last 30 days after surgery to catch any additional morbidity even after discharge from the hospital.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective PD;
- •Male and females ≥ 18 years;
- •Upfront or after neoadjuvant therapy surgery is allowed;
- •The ability of the subject to understand the character and individual consequences of the clinical trial;
- •Written informed consent.
排除标准
- •Patients undergoing emergency surgery;
- •Informed consent withdrawal;
- •Inability to perform the resection for any reason;
- •Total or distal pancreatectomy.
结局指标
主要结局
The difference in length of hospital stay between the PPAP and the non-PPAP group
时间窗: up to hospital discharge, an average of 30 postoperative days
Length of hospital stay is calculated from the day of surgery to discharge.
The incidence of unplanned ICU admissions and hospital readmission in the PPAP group compared to the non-PPAP one.
时间窗: 30 postoperative days
Only an unplanned need for intensive care will be defined as intensive care unit (ICU) stay. Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery.
The difference in hospital costs among the different grades of severity according to the ISGPS grading system22: no PPAP or POH, POH, PPAP grade B, and PPAP grade C groups.
时间窗: 30 postoperative days
Total hospital costs will comprise the cost of the index admission and every surgery-related readmission within 30 days from the index surgery. Costs will be inflation-adjusted using the standardized national consumer price index and normalized to adjust the variability inherent to different health systems and institutions.
The incidence of PPAP
时间窗: 30 postoperative days
The incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system.
次要结局
- Incidence and descriptive analysis of radiological features consistent with PAPP at postoperative imaging retrieved at different time points.(30 postoperative days)
- Correlation between postoperative serum amylase/serum lipase activity (U/L) and radiologic feature consistent with PPAP retrieved at postoperative imaging.(30 postoperative days)
- Incidence of postoperative mortality.(30 postoperative days)
- Incidence and severity of postoperative morbidity.(30 postoperative days)