Drain Amylase Levels After Pancreatoduodenectomy. Validations of New cut-of for the Stratification of Postoperative Complications, Surgical Drains Management and Use of Postoperative Abdominal CT: (The DALCUT) Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Validate the ability of the diameter (in cm) of abdominal collection detected during the contrast-free abdomen CT in POD3 to predict risk of biliary fistula
研究概览
简要总结
Pancreatic fistula (PF) represents the Achille's heel of pancreatic surgery and is the main cause of postoperative morbidity since it can determine the onset of others complications such as abdominal abscesses, surgical wound infections, sepsis and bleeding, that can sometimes be fatal.
During a previous study conducted at the University Campus Bio-Medico of Rome, Department of General Surgery there were identified cut-offs of amylase levels on the abdominal drainage fluid dosed in I postoperative day (POD1) and III postoperative day (POD3) which can significantly predict PF and in particular clinically relevant fistulas as well as abdominal collections and biliary fistulas, if related to some specific findings of the abdominal CT routine performed in POD3.
The aim of this research project is to validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant PF and to validate the use of abdomen CT without contrast in POD3 in patients with increased risk of biliary fistula.
详细描述
Pancreatic Fistula (PF) remains the main complication following pancreatic surgery with an incidence described in up to 45% of cases, even in high volume centers. It can determine the onset of other complications such as abdominal abscesses, surgical wound infections, sepsis and bleeding, sometimes fatal. In addition, the economic impact due to the extension of hospital stay and the management costs of the PF are not of secondary importance.
The International Study Group on Pancreatic Fistula (ISGFP) has standardized the definition of PF identifying it as "the leak from a surgical or percutaneous drainage of any measurable quantity of fluid, starting from the third postoperative day (POD3), with an amylase content three times higher than the upper normal limit of serum amylases. " However, according to this definition, all patients who satisfy this condition, even in the absence of any clinical signs or symptoms, are defined as suffering from pancreatic fistula.
To overcome this, a three grades classification system of PF was introduced, based on the clinical impact:
- Grade A: It is biochemical fistula; No intervention needed, not significant change of the post-operative hospital stay.
- Grade B: it requires an extension of the post-operative hospital stay, the permanence of surgical drains, the possible positioning of further drainages under radiological guide, antibiotic therapy and the use of artificial, enteral or parenteral nutrition;
- grade C: re-surgery is needed. Grade B and C represent clinically relevant fistulas. It is therefore evident that a correct definition of PF and its grade (A, B, C) can only be formulated "a posteriori".
However, considering the high prognostic impact of PF, it is needful to identify risk factors and diagnostic tools capable of stratifying patients at risk of pancreatic fistula and reach an early diagnosis in order to plan better plan both the treatment of it and the complications that may arise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years old
- •acquisition of informed consent for surgery and for inclusion in the study;
- •elective open or laparoscopic PD
排除标准
- •age <to 18 years;
- •absence of informed consent for inclusion in the study;
- •Emergency surgery;
- •other pancreatic resections (not PD).
研究组 & 干预措施
Drain removal
Patients that fulfill criteria for surgical drains removal
干预措施: Surgical Drains Management (Procedure)
结局指标
主要结局
Validate the ability of the diameter (in cm) of abdominal collection detected during the contrast-free abdomen CT in POD3 to predict risk of biliary fistula
时间窗: From postoperative day 1 to postoperative day 90
The relation between abdominal collections (measured in centimeters) detected with abdomen CT scan and the risk of develop a biliary fistula.
Validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant FP
时间窗: From postoperative day 1 to postoperative day 90
The management of drainages and the execution of the abdomen CT scan in Postoperative day 3 will be managed on the basis of the outcome of the assay of amylase levels performed on fluid collected by surgical drains. This evaluation will be performed each day in the first three postoperative days or until drains removal.
次要结局
未报告次要终点
研究者
Damiano Caputo
Associate Professor of Surgery
Campus Bio-Medico University