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临床试验/NCT00698880
NCT00698880已完成2 期

Sequential Preoperative Ipsilateral Hepatic Vein Embolization After Portal Vein Embolization to Induce Further Liver Regeneration in Patients With Hepatobiliary Malignancy

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
13
试验地点
2
主要终点
Future remnant left liver volume on multidetector dynamic CT scans

研究概览

简要总结

Portal vein embolization (PVE) induces shrinkage of the embolized lobe and compensatory enlargement of the non-embolized lobe, but it does not always induce sufficient liver regeneration. There was no effective method to accelerate liver regeneration in addition to PVE yet.

This study intends to assess the effect of ipsilateral hepatic vein embolization (HVE) performed after Portal vein embolization (PVE) on liver regeneration. During a 1-year study period, preoperative HVE would be performed on 10 or more patients who had shown limited liver regeneration after PVE awaiting right hepatectomy. Sequential application of PVE and HVE may be safe and effective in facilitating contralateral liver regeneration by inducing more severe liver damage than PVE alone.

详细描述

To prospectively assess the effect of ipsilateral HVE after PVE on liver volume change, this study was designed to continue for 12 months, from March 2007 to February 2008.

This study protocol was approved by our institutional review board, under the condition that, for patient safety, more than one occurrence of accidental coil migration into the heart or lung would lead to study discontinuation. The clinical significance of this risk had not been fully assessed, although it might not be seriously harmful. In addition, informed consent and permission for each PVE and HVE were obtained separately from each patient and/or his/her family members.

The indications for right PVE are patients undergoing right hepatectomy or more extensive liver surgery for hepatobiliary malignancy, but having small FLRs, with mean values less than 40% of total liver volume. Patients with large liver masses are excluded because their parenchymal resection rates were much lower than 60%. For patients with perihilar cholangiocarcinoma, placement of multiple biliary drains was preferred to decompress the entire biliary system, and the timing of PVE was set to when serum total bilirubin level became lower than 5 mg/dL.

The right internal jugular vein was punctured with an 18-gauge needle and a 9-F long sheath (Cook; Bloomington, IN) was inserted. The right hepatic vein (RHV) was selected using a 5-F cobra catheter (Cook) and a 0.035-inch guide wire (Terumo; Tokyo, Japan). Insertion of the guide wire toward the dorsal side was checked with a right lateral view to confirm that it was correctly inserted into the RHV. A 9-F sheath was inserted at the proximal portion of the RHV, followed by placement of a Tulip filter (retrievable vena cava filter; Cook) or a Trap-Ease filter (Cordis; Miami, FL) to prevent migration of deployed coils during embolization of the RHV. The cobra catheter was then advanced into the RHV and the main RHV branches were embolized with coils 8 to 12 mm in diameter (nester embolization coils; Cook).

Multidetector dynamic CT scans were routinely performed before PVE to assess gross liver volume change and tumor progression, and CT scans were performed every week after PVE, HVE, and hepatectomy. All CT images were reconstructed as sections 3 mm thick. The CT images were stored in a Picture Archiving and Communication System (PACS; Petavision; Asan Medical Center, Seoul, Korea), enabling image processing and various measurements including volumetry. In patients undergoing combined caudate resection, the volume of the caudate lobe was not included in the FLR volume. TLV and FLR volume before PVE were used as the baseline liver volumes for liver size comparison.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients showing small future remnant liver < 40% of whole liver volume

排除标准

  • Patients showing small future remnant liver > 40% of whole liver volume
  • Inoperable tumor extent

结局指标

主要结局

Future remnant left liver volume on multidetector dynamic CT scans

时间窗: 2 weeks after HVE

次要结局

  • Immunohistochemical stainings(during operation)

研究者

申办方类型
Other

研究点 (2)

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