Influence of Pancreatic Transection With Cavitron Ultrasonic Surgical Aspirator (CUSA) on Postoperative Pancreatic Fistula Incidence - a Prospective Randomised Controlled Trial: the PANCUT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Postoperative pancreatic fistula incidence
研究概览
简要总结
Objective: To compare the outcomes after elective pancreatic resections using cavitron ultrasonic surgical aspirator (CUSA) and selective closure of small blood vessels and branch pancreatic ducts versus surgical scalpel or stapler for the transection of pancreatic tissue.
Study design: A randomized controlled, single centre trial.
Study population: Two groups of 80 patients (160 in total) scheduled for elective open pancreaticoduodenectomy (PD) for any indication.
Intervention: Transection of pancreatic tissue with CUSA.
Control: Standard transection of pancreatic tissue with surgical scalpel (in PD) or stapler (in DP)
详细描述
Rationale: Postoperative pancreatic fistula (POPF) is one of the major causes of morbidity and mortality after pancreatic resections. There is no predominant surgical technique of pancreatic stump closure in distal pancreatectomy (DP) or formation of pancreaticojejunostomy in pancreaticoduodenectomy (PD) proven to prevent/lower POPF incidence. Cavitron ultrasonic surgical aspirator (CUSA) selectively removes tissue parenchyma, evading blood vessels and pancreatic ducts which could consequently be selectively ligated. Such technique could anull pancreatic juice drainage from branch ducts and provide better (skeletonised) view of the main duct to from an anastomosis (or to ligate it in DP) and thus lower the incidence of POPF formation.
Objective: To compare transection of pancreatic tissue with CUSA and selective closure of small blood vessels and branch pancreatic ducts with transection with surgical scalpel or stapler in elective pancreatic resections regarding the incidence of POPF.
Study design: A randomized controlled, single centre trial. The study protocol was designed according to the SPIRIT guidelines.
Study population: Two groups of 80 patients (160 in total) scheduled for elective open pancreaticoduodenectomy (PD) for any indication.
Intervention: Transection of pancreatic tissue with CUSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients aged 18 years or more
- •Patients capable of understanding the provided information about the study
- •Patients with signed informed consent
- •Planned elective pancreaticoduodenectomy for any indication
排除标准
- •Patients aged less than 18
- •Patient incapable of understanding the provided information about the study
- •Pregnancy
- •Previous surgical procedures on pancreas
- •Immunosuppressive therapy
- •Preoperative radiotherapy
结局指标
主要结局
Postoperative pancreatic fistula incidence
时间窗: 30 days
Evaluation and incidence of postoperative pancreatic fistula
次要结局
- Postoperative septic complications(90 days)
- Hospital stay(90 days)
- Volume of intraoperative blood loss(1 day)
- Number of postoperative interventions(90 days)
- Operative time(1 day)