First-day Versus Early Drain Removal Following Pancreaticoduodenectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- occurrence of one or more pancreas-specific complications
研究概览
简要总结
Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome. Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity. The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded.
AIM we aim to compare postoperative surgical outcomes after PD in patients with low/medium risk for POPF (ISGPS risk class A-B-C), who undergo POD1 drains removal versus POD3 removal.
Primary aim: 1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH). Secondary aims: occurrence of fluid collection, sepsis, SSI, need for reintervention, length of stay, CD>3, 90 days mortality, re-admission.
Study Design:
This is a randomized, controlled, open-label study. All patients will be randomized on POD1, using computer-generated randomization codes.
Group A: Drain removal on POD 1 (in case of POD 1 DFA< 300 U/L) Group B: Drain removal on POD 3 (in case of POD 1 DFA< 300 U/L)
详细描述
Introduction Pancreatic surgery is a complex discipline with a high risk of post-operative morbidity such as pancreatic fistula (POPF) with variable impact on clinical outcome, fluid collection and hemorrhage. For such reason the intraoperative placement of intra-abdominal drains (ID) to early detect, mitigate, and manage post-operative complications is still considered to be a routine practice.
Controversies on ID placement have emerged from both randomized and non-randomized clinical studies investigating its possible role in increasing POPF and postoperative morbidity as well as prolonged hospital stay. According to Conlon et al the presence of drains failed to reduce either the need for interventional radiologic drainage or surgical exploration for intraabdominal sepsis and was associated with the development of more intra-abdominal abscesses, collections, or fistulas. Some authors report significantly higher postoperative abdominal complications after late removal of ID. A prolonged period of drain insertion is associated with a higher rate of postoperative complications with increased hospital stay and costs, not to mention that dislocation of intra-abdominal drains is an early and frequent event after major pancreatic resection.
The optimal timing for drain removal after PD is still a subject of debate: most studies have shown that outcomes are best when ID are removed in postoperative day (POD) 3 when POPF is excluded (given a specific cut off for drain fluid amylase, DFA).
Even though many authors advocate early ID removal to prevent intra-abdominal infection or fistula, in clinical practice many surgeons may feel more comfortable to maintain IDs for a prolonged period (more than 3 days) even when criteria for POPF or other abdominal complications are not met.
In some studies correlation between drain fluid amylase (DFA) in POD1 after pancreatic resections and development of POPF has been examined, defining ideal cut-off points ranging between 5.000U/L and 90 U/l3-17-20-21 (depending on intraoperative risk stratification) that can be used to achieve the best timing for drain removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients (age ≥ 18 or < 85 years) undergoing elective pancreaticoduodenectomy providing informed consent.
- •Intraoperative low to moderate risk for POPF (ISGPS class A-B-C)
- •POD 1 DFA < 300U/L
排除标准
- •Age <18 or >85
- •Patients with high risk of developing pancreatic fistula (ISGPS class D)
- •Intraoperative positioning of external or internal pancreatic stent
- •POD 1 DFA ≥300
- •Sinister appearance of drain effluent (defined as dark brown to clear "spring water" fluid that looks like pancreatic juice contaminated) as mentioned in literature3-22
- •Early post-pancreatectomy hemorrhage
- •Intraoperative conditions different from POPF risk, requiring prolonged intrabdominal drains
- •Previous bilio/pancreatic surgery
- •Allergy to drain materials
- •Significant coagulation disorders
- •Patients unable to provide informed consent.
- •Clinical suspect of another surgery-related fistula different than POPF
结局指标
主要结局
occurrence of one or more pancreas-specific complications
时间窗: up to 90 days after surgery
complications are defined according to ISGPS as:1) grade B/C POPF; 2) post-pancreatectomy hemorrhage (PPH).
次要结局
- occurrence of general post operative complications(up to 90 days after surgery)
研究者
Isabella Frigerio
MD PhD
Casa di Cura Dott. Pederzoli
