Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Randomized Trial on Standard Open Versus Minimally Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Baki Topal
- 试验地点
- 1
- 主要终点
- intra-operative blood loss
研究概览
简要总结
The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an important factor that determines the occurrence of postoperative complications. Therefore, any significant reduction of intra-operative blood loss will benefit the peri-operative course.
详细描述
Pancreaticoduodenectomy (PD) is the only therapeutic option to cure patients suffering from pancreatic head or peri-ampullary tumors. The standard approach in PD is open surgery (OPD). With advancing technology, data from expert centers suggest minimally invasive or laparoscopic PD (LPD) to be safe and feasible, though randomized studies are lacking to show the clinical benefits of LPD vs. OPD.
Advantages of minimally invasive surgery over open surgery are reduced tissue damage, surgical trauma and immunosuppression.
The general objective of this study is to compare the intra-operative efficacy of LPD vs. OPD, and in particular the amount of intra-operative blood loss.
Study design Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous other type of surgery will be excluded from the study.
Two experienced surgeons will perform all procedures; RA will perform the open and BT the laparoscopic procedures. A pylorus-resecting PD will be followed by a trans-mesocolic end-to-side hepatico-jejunostomy (HJS), a pancreatico-gastrostomy (PGS), and an ante-colic gastro-enterostomy (GES). Da Vinci robotic assistance of the reconstruction in LPD is allowed for the HJS and the PGS, while the GES will be done with endo-staplers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor
- •Age between 18 to 80 years
- •Patients with and without pre-operative biliary drainage (for obstructive jaundice)
- •Pre-operative radiotherapy, chemotherapy, or biological is allowed
- •PD for IPMN is allowed
排除标准
- •Planned concomitant surgical procedures such as simultaneous colonic resection etc.
- •Expected/planned reconstruction of the portal vein or superior mesenteric vein
- •Any arterial reconstruction at the time of surgery
- •Age < 18years
- •Pregnancy
- •PD for chronic pancreatitis
- •PD for pancreatic trauma
- •PD for post-ERCP complications
结局指标
主要结局
intra-operative blood loss
时间窗: day 0 (at the end of surgery)
the amount of intra-operative blood loss (ml) at the end of surgery (d0)
次要结局
- Surgical resection margin(day 30)
- length of hospital stay after surgery(day 30; 60; 90; 180)
- hospital costs(year 1 & 2)
研究者
Baki Topal
Professor of Surgery
University Hospital, Gasthuisberg