PANDREAS. Prophylactic Abdominal Drainage vs no Drainage After Distal Pancreatectomy: a Multicentre Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 主要终点
- Clinically relevant postoperative pancreatic fistula
研究概览
简要总结
Postoperative pancreatic fistula (POPF) is a major source of morbidity and mortality after pancreatic resection, especially after distal pancreatectomy (PD). Today, POPF remains one of the main causes of hospital length of stay and healthcare costs. Numerous surgical techniques have been tested to reduce its incidence without success, so the current standard for the management of POPF, and the avoidance of associated complications, is intraoperative drain placement. However, surgically placed drains are not without risk. In recent years many studies, mostly retrospective, have attempted to determine whether omission of prophylactic drainage is associated with increased morbidity. These studies suggest that patients may benefit from not having a drain placed. This evidence challenges standard practice and the debate of whether or not to place a drain after distal pancreatectomy remains open. The investigators designed a prospective multicentre randomised non-inferiority study to determine whether prophylactic intraoperative drainage is associated with a lower morbidity rate after distal pancreatectomy.
详细描述
A prospective, randomised, multicentre, multicentre, randomised non-inferiority study is designed. The aim is to study whether patients who undergo distal pancreatectomy can benefit from the non-placement of a drain in terms of clinically relevant postoperative pancreatic fistula and Clavien-Dindo morbidity greater than or equal to 3.
Information will be collected for all patients undergoing distal pancreatectomy surgery at the collaborating centres who, upon invitation, voluntarily agree to participate in the study. Those who have agreed to participate, given written consent and meet the inclusion criteria and none of the exclusion criteria will be randomly assigned to one of the following treatment groups:
- Control group: patients who, after distal pancreatectomy, in whom abdominal drainage is placed.
- Intervention group: patients who, after distal pancreatectomy, will be omitted the placement of an abdominal drain.
Following the postoperative pancreatic fistula score according to the DISPAIR criteria, patients included in the present study will be stratified according to the preoperative risk of postoperative pancreatic fistula into: extreme, high, moderate and low.
The standards of surgical technique to be followed in both open and minimally invasive distal pancreatectomy were agreed by consensus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Adult patients (over 18 years of age) undergoing elective distal pancreatectomy surgery for any indication, with or without splenectomy, minimally invasive or open. It is not necessary to integrate gender perspective as it is not relevant and there is no influence on the results of POPF or morbidity.
- •Signed informed consent was obtained from each of the patients included in the study.
排除标准
- •Patients undergoing distal pancreatectomy as a secondary procedure
- •Additional liver, gastric or colonic resection
- •Pregnancy
- •Participation in another study
- •History of previous surgery involving the pancreas
- •Patients with American Society of Anaesthesiologists classification 4
- •Arterial resection other than the splenic artery
结局指标
主要结局
Clinically relevant postoperative pancreatic fistula
时间窗: From first postoperative day until day 30 after surgery
The investigators define a clinically relevant pancreatic fistula following the 2016 update of the International Study Group (ISGPS) definition. According to this, a Clinically Relevant Postoperative Pancreatic Fistula refers to a grade B or C. Grade B requires a change in the postoperative management; drains are either left in place \>3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.
次要结局
- Reoperation.(From first postoperative day until day 90 after surgery)
- Length of hospital stay(From first postoperative day until day 90 after surgery)
- In-hospital mortality.(From first postoperative day after surgery.)
- To study the role of amylase production in drainage in the development of postoperative pancreatic fistula.(From first postoperative day until the fifth day after surgery)
- Delayed gastric emptying.(From first postoperative day until day 90 after surgery)
- To study the role of biochemical parameters C-Reactive Protein in the development of postoperative pancreatic fistula.(From first postoperative day until the fifth day after surgery)
- Surgical wound infection.(From first postoperative day until day 90 after surgery)
- Clavien-Dindo morbidity greater than or equal to 3.(From first postoperative day until the ninth month after surgery)
- Intensive care admission.(From first postoperative day until day 90 after surgery)
- Percutaneous drainage.(From first postoperative day until day 90 after surgery)
- Abdominal collections(From first postoperative day until day 90 after surgery)
- To study the role of Neutrophil-Lymphocyte Ratio (NLR) in the development of postoperative pancreatic fistula.(From first postoperative day until the fifth day after surgery)
- To examine the relevance of the neutrophil-lymphocyte ratio in the exclusion of postoperative pancreatic fistula after distal pancreatectomy.(From first postoperative day until the fifth day after surgery)
- Postoperative bleeding.(From first postoperative day until day 90 after surgery)
- Blood transfusion.(From first postoperative day until day 90 after surgery)
- Mortality.(From first postoperative day until day 90 after surgery)
- To study the role of serum amylase in the development of postoperative pancreatic fistula.(From first postoperative day until the fifth day after surgery)
- Readmission.(From first postoperative day until day 90 after surgery)
- To identify subgroups of patients according to their risk for postoperative pancreatic fistula(From first postoperative day until the fifth day after surgery)
- To analyse the quality of life of patients undergoing distal pancreatectomy(From first postoperative day until the ninth month after surgery)
- To compare the quality of life of patients who undergo distal pancreatectomy according to the placement or non-placement of an intraoperative drain(From first postoperative day until ninth month after surgery)