Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Rate of Pancreatic fistula
研究概览
简要总结
Several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP). The appropriate closure technique of the pancreatic stump is still debated. There is no published experience about the comparison of the Endo GIA Reinforced Reload with Tri-Staple Technology (TS) versus Harmonic Focus (US) after distal pancreatectomy (DP) regarding the reduction of POPF.
The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after DP, depending upon the transection technique (TS versus US).
This is a randomized controlled, multicenter, patient-blinded, superiority trial. This protocol was designed according to the SPIRIT guidelines.
Two groups of 76 patients (152 in total) with an indication for elective minimally invasive or open DP for a lesion of the body-tail of the pancreas. The two techniques analyzed are Endo GIA Reinforced Reload with Tri-Staple Technology (TS) and Harmonic Focus (US) as control.
The primary endpoint is to evaluate the incidence of CR-POPF rate after DP. Secondary endpoints are intraoperative outcomes (blood loss, operative time and conversion of the minimally invasive procedure), postoperative outcomes (complications rate; hospitalization parameters to 90 days; mortality) and treatment costs.
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
- Single (Participant)
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
- •Scheduled for elective DP via a minimally invasive (laparoscopic or robotic) or open technique, either preserving the spleen or with splenectomy, depending on the diagnosis/nature of the tumor
- •ASA score < 4
- •Ability of the subject to understand character and individual consequences of the clinical trial
- •Written informed consent
排除标准
- •Pancreas thickness >17mm measured at the intraoperative ultrasound at the pancreatic transection level
- •Metastatic disease
- •Kidney or adrenal gland resection
- •Arterial resection (celiac axis, superior mesenteric artery, hepatic artery)
- •Intestinal resections and anastomoses or stoma
- •Acute necrotizing and chronic pancreatitis
- •Immune suppressed patients
- •Pregnant women
- •Patients with contraindications for distal pancreatectomy
- •Impaired mental state or language problems
研究组 & 干预措施
ultrasonic shears
干预措施: ultrasonic shears (Device)
Stapler
干预措施: Stapler (Device)
结局指标
主要结局
Rate of Pancreatic fistula
时间窗: 90 days
pancreatic fistula according to International Study Group of Pancreatic Surgery (ISGPS) 2017 definition
次要结局
- Operative time(intra-operatively)
- Rate of postoperative overall and specific complications(30 days, 90 days)
- Rate of re-operations or percutaneous drainage(30 days, 90 days)
- Cost-analysis(90 days)