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选择性门静脉结扎联合肝切除术治疗大肝癌:2A 期 IDEAL 前瞻性病例系列研究。

Selective devascularization treatment for large hepatocellular carcinoma: Stage 2A IDEAL prospective case series.

机构信息

Department of Surgery, Ribat University Hospital, The National Ribat University, Sudan.

Department of Interventional Radiology, Ribat University Hospital, Sudan.

出版信息

Int J Surg. 2019 Aug;68:134-141. doi: 10.1016/j.ijsu.2019.06.014. Epub 2019 Jun 29.

Abstract

BACKGROUND

Rapid growth and invasiveness of hepatocellular carcinoma (HCC) largely depends on its vascularity and active angiogenic capacity. That feature was used to control the tumor in the past with some limitations. These deficiencies were addressed in our new procedure by hepatic artery ligation and extrahepatic collaterals division (HALED) of the liver lobe containing large HCC. This study tried to assess the feasibility, safety and the short term effects of HALED.

MATERIALS AND METHODS

This is a prospective stage 2a development IDEAL (Idea, Development, Exploration, Assessment and Long-term monitoring) case series. It included adult patients with large-sized HCC (diameter > 5 cm) subjected to HALED carried out in our center during five years' trial evaluating one-month postoperative outcomes. Patients will be reported prospectively in a sequential order with explanation of reasons for rejected cases and description of changes to technique or indication as the procedure evolved. This study registry number is NCT03129685 at the ClinicalTrials.gov.

RESULTS

The first HALED operation was carried out safely on 2013, followed by nineteen patients by 2018. Patients' mean age (±standard deviation) was 62·45 (±9·27), range 38-76 years. Eleven (55%) patients had tumors diameter > 10 cm 13 (65%) patients were advanced BCLC stage. Seven modifications were made on the technique and indications of the procedure towards stability. According to the modified response evaluation criteria in solid tumors, 13 patients (65%) attained complete response. Operative mortality was 5% (one patient) and major morbidity was 10% (two patients). Liver infarction and abscess formation were not noticed in this study.

CONCLUSION

Our forerunner study showed that HALED for large HCC is safe and induces tumor necrosis. Further long-term studies are suggested before starting the 2b stage.

摘要

背景

肝细胞癌(HCC)的快速生长和侵袭性在很大程度上取决于其血管生成和活跃的血管生成能力。过去,人们利用这一特征来控制肿瘤,但存在一些局限性。在我们的新手术中,通过结扎肝动脉和肝叶内的肝外侧支血管(HALED)来处理包含大 HCC 的肝叶,解决了这些缺陷。本研究旨在评估 HALED 的可行性、安全性和短期效果。

材料和方法

这是一项前瞻性 2a 期 IDEAL(理念、开发、探索、评估和长期监测)病例系列研究。纳入了在我们中心接受 HALED 治疗的直径>5cm 的成人大 HCC 患者,在五年的试验中评估术后一个月的结果。将按照顺序对患者进行前瞻性报告,解释拒绝病例的原因,并描述随着手术的发展技术或适应证的变化。本研究的注册号为 NCT03129685,在 ClinicalTrials.gov 上注册。

结果

2013 年首次安全实施 HALED 手术,随后在 2018 年对 19 名患者进行了手术。患者的平均年龄(±标准差)为 62.45(±9.27)岁,年龄范围为 38-76 岁。11 名(55%)患者的肿瘤直径>10cm,13 名(65%)患者为进展期 BCLC 分期。该手术的技术和适应证进行了 7 项修改,以达到稳定。根据实体瘤反应评估标准,13 名患者(65%)达到完全缓解。手术死亡率为 5%(1 例),主要并发症发生率为 10%(2 例)。本研究未发现肝梗死和脓肿形成。

结论

我们的前期研究表明,HALED 治疗大 HCC 是安全的,可以诱导肿瘤坏死。在开始 2b 期研究之前,建议进行进一步的长期研究。

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