Post-Operative Acute Pancreatitis After Pancreaticoduodenectomy: A Prospective Study in the Setting of a High-volume Center.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- the difference in apparent diffusion coefficient (ADC) values at diffusion-weighted (DW) MRI in the PPAP group compared to patients without PPAP.
研究概览
简要总结
The occurrence of post-pancreatectomy acute pancreatitis (PPAP) can critically impact outcomes after pancreaticoduodenectomy. Although diagnosing a PPAP can be challenging, its identification appears crucial as it can trigger additional morbidity. However, due to the early onset in the perioperative period, the actual spectrum of its early phases has not been systematically explored yet. For this reason, the present study will compare some early biochemical evidence of pancreatic stump damage to morphological changes evident at postoperative imaging.
The postoperative evaluation of serum and/or urine pancreatic enzymes and the radiologic assessment are included in everyday clinical practice. However, the timing and the clinical relevance of such findings mostly rely on the single-institution experience.
This study aims to characterize PPAP by investigating its early radiologic, biochemical, and clinical spectrum of either local or systemic changes associated.
详细描述
The occurrence of an acute inflammatory process of the pancreatic parenchyma after pancreatic resections has been reported in the literature, but the actual existence of a clinically evident post-pancreatectomy acute pancreatitis (PPAP), defined as a distinct postoperative complication, has been traditionally challenged or, at least, considered to be a rare event.
Emerging evidence, however, defines PPAP as an acute inflammatory/ischemic condition of the pancreatic remnant, able to trigger further postoperative morbidity.
The assessment of ischemic damage of the organ subjected to surgery was also evaluated in other scenarios, such as for the post-cardiac surgery myocardial infarction (MI) and the post-neurosurgery stroke. These ischemic complications, besides having well-defined biochemical features, maybe detected early on post-operative magnetic resonance imaging (MRI). The decrease of pancreatic perfusion may, in some instances, lead to an altered signal in diffusion-weighted images (DWI) and apparent diffusion coefficient (ADC) maps. DWI MRI with Intravoxel incoherent motion (IVIM) sequences have also recently emerged as a key tool to provide quantitative estimates of physiological parameters associated with perfusion and permeability in vivo and can provide information on alterations of tissue cellularity, membrane-cell integrity, and the extracellular space.
The recent PPAP definition has left some unsolved issues, including the need to investigate the role of lipases as a diagnostic criterion, the actual spectrum of PPAP complications, the proper timing for postoperative radiological evaluation, and the preferred imaging modality for PPAP assessment.
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
- •Male and females ≥ 18 years;
- •Scheduled for elective PD;
- •ASA score < 4;
- •High-quality preoperative cross-sectional imaging of the abdomen performed roughly within one month before surgery;
- •Upfront or after neoadjuvant therapy surgery is allowed;
- •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;
- •Patients with high serum pancreatic amylase or lipase before surgery;
- •Chronic use of steroids;
- •Informed consent withdrawal;
- •Pancreaticogastrostomy (PG);
- •Use of octreotide analogs;
- •Inability to perform the resection for any reason;
- •Total or distal pancreatectomy;
- •Need to extend the resection to the pancreas body for any reason.
- •Inability to undergo MRI because of contraindications (e.g. claustrophobia, presence of non-MRI-compatible metal implants)
结局指标
主要结局
the difference in apparent diffusion coefficient (ADC) values at diffusion-weighted (DW) MRI in the PPAP group compared to patients without PPAP.
时间窗: postoperative day 3 (72 h after the index surgery).
DW-MRI studies will be performed on a 1.5 T scanner using a multi-channel phased-array torso coil.
次要结局
- postoperative acute pancreatitis and morbidity(90 days after surgery)
- intraindividual correlation between longitudinal assessment of serum pancreatic enzymes(5 days after surgery)
- Postoperative acute pancreatitis incidence(90 days after surgery)