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临床试验/NCT03551470
NCT03551470Unknown不适用

Robot-assisted Resection of Colorectal Cancer and Synchronous Liver Metastases:Preliminary Experience, Technique and Literature Review

Azienda Ospedaliera San Giovanni Battista1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
22
试验地点
1
主要终点
Short-term perioperative surgical outcomes

研究概览

简要总结

Up to 25% of newly diagnosed patients with colorectal cancer (CRC) have liver metastases (LM). Simultaneous colorectal and hepatic resection has been proven to be a safe and effective approach in dealing with metastatic colorectal cancer.

The aim of this paper is to analyse perioperative and oncological outcomes of minimally invasive (laparoscopic and robotic) one-stage simultaneous resection of liver metastases and colorectal tumor in selected patients affected by colorectal cancer and synchronous liver metastases.

详细描述

From October 2012 to March 2018 a minimally invasive one-stage resection was offered to selected patients referred to the investigator's institution with a diagnosis of CRC and synchronous LM, irrespective of the size and location of the primary and metastatic disease. When feasible, a fully-robotic colorectal and liver resection was performed. Prior consent was obtained and full treatment options where submitted to all patients treated. Data collected were prospectively analyzed.

Diagnosis and pre-operative staging were achieved with pancolonoscopy with biopsies and, where contraindicated or not feasible, with CT colonography.

Pelvic MRI with rectal cancer protocol was used for local staging of rectal cancer and total-body contrast-enhanced computed tomography (CT) and liver contrast-enhanced magnetic resonance imaging (MRI) for investigation of metastases. In selected cases a CEUS (contrast-enhanced ultrasound) or liver biopsy was performed in order to achieve a diagnostic definition.

All cases were discussed at multidisciplinary team meeting. Criteria for neoadjuvant chemotherapy were liver unresectability with a potential incomplete liver resection with anticipated positive surgical margins and an insufficient liver remnant.

Absolute contraindications for minimally invasive simultaneous surgery were considered unfitness for surgery due to comorbidities not allowing long operative time, the number of lesions in parenchymal sparing surgery (generally >5), the pre-operative prediction of vascular resection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • colorectal primary tumor with synchronous liver metastases
  • eligibility for minimally-invasive surgery

排除标准

  • unfitness for prolonged operative time
  • liver lesions >5
  • pre-operative prediction of vascular resection

结局指标

主要结局

Short-term perioperative surgical outcomes

时间窗: intra-operative - within 30 post-operative day

Morbidity

Mortality

时间窗: Intra-operative -within 30 post-operative day

Blood loss

时间窗: Intra-operative

Measured in mL

Conversion rate

时间窗: Intra-operative

Operative time

时间窗: Intra-operative

Measured in minutes

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera San Giovanni Battista
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele De Rosa

Principal Investigator

Azienda Ospedaliera San Giovanni Battista

研究点 (1)

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