跳至主要内容
临床试验/NCT02121886
NCT02121886Unknown不适用

To Evaluate the Safety and Outcome of the Parietal Peritoneum as a Substitute Graft for Venous Reconstruction in Hepatobiliary and Pancreatic Surgery

Beaujon Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Safety and venous patency

研究概览

简要总结

To evaluate the safety and outcome of the parietal peritoneum for venous reconstruction HPB surgery. Although the parietal peritoneum had already been used and published for the reconstruction of the vena cava, however this one was never described or described in HPB surgery

详细描述

Improvements in surgical techniques, perioperative management and effective chemotherapy regimens, have increased the resectability of malignant hepatobiliary and pancreatic tumors when associated with vascular invasion. Therefore, simultaneous vascular resection is increasingly required to obtain an adequate resection margin and improve patient definite survival. Although most vascular resection associated with pancreatectomy can be reconstructed by simple venorraphy or end-to-end anastomosis, a segmental or lateral vacular graft (VG) can be necessary in 8-12 % of cases. Vascular reconstruction can be planned preoperatively if the vascular invasion is evident and an appropriate VG can be prepared. Differents sources of VG are available including autogenous veins , synthetic such as polytetrafluoroethylene (PTFE) , cryopreserved and veins from the resected liver. However the decision to perform vascular resection may be made during dissection due to vascular invasion or injury and even occasionnally taken while the mesentericoportal vein (MPV) or vena cava (VC) are occluded. In this emergency situation, an urgent and easily available graft is necessary to prevent prolonged ischemia. The difficulty of anticipating the need for these vascular resections during HPB surgery, has lead certain authors including those in our group to use either the veins from the resected liver, the umbilical vein or the parietal peritoneum (PP) for vena cava reconstruction. The aim of our study is to evaluate the safety and outcome of the parietal peritoneum as a substitute patch for venous reconstruction during HPB surgery in emergency and elective situations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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
是

入选标准

  • •All patients admitted to HPB unit and schudeled for major liver or pancreatic resections with suspected venous invasion. Venous invasion is suspected on CT scan (vein narrowing or disappearance of the fat plane between the vein and the tumor) performed within 1 month of surgical resection. Informed consent will be obtained and the parietal peritoneum will be used as a substitute graft for resection-reconstruction in these patients if intra-operative exploration confirmed this venous invasion

排除标准

  • •Patients who refuse to participate and patients with suspected peritoneal carcinomatosis or if intra-operative exploration confirmed the presence of peritoneal carcinomatosis

研究组 & 干预措施

Parietal peritoneum

Experimental

干预措施: venous reconstruction with the parietal peritoneum (Procedure)

结局指标

主要结局

Safety and venous patency

时间窗: Up to 4 months

The primary outcome of this study will be the safety and venous patency. Safety means "to see if the parietal peritoneum is rigid and there is no tearing of bleeding in the reconstructed area, related to venous pressure", this safety will be assessed clinically (exteriorized bleeding from the reconstructed zone and on CT scan to search for local hematoma). Patency will be assessed by regular CT scan performed on postoperative day 8,30,90 and 120. On CT scan, this evaluation will include the degree on venous stenosis (0%, \<25%, 25%-75%, \>75%, thrombosis) compared to non reconstructed vein, the presence of thrombosis with collateral venous circulation or venous enlargement in the reconstructed area

次要结局

  • Long-term venous Patency(Up to 6 months)

研究者

发起方
Beaujon Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Safi Dokmak

MD

Beaujon Hospital

研究点 (1)

Loading locations...

相似试验

The Parietal Peritoneum as a Substitute Graft for... | 临床试验