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Robot-assisted IVOR-LEWIS Esophagectomy (RAILE)

2022年1月3日 更新者：Hecheng Li M.D., Ph.D、Ruijin Hospital

Robot- Assisted Ivor-Lewis Esophagectomy for Esophageal Cancer: Short- Term and Long Term Outcomes of a Single-Arm Phase II Trial

Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer. It is generally accepted that comparing to open resections, MIE results in decreased postoperative pain, faster recovery times, and shorter hospital stays with comparable oncologic outcomes. However, MIE poses an important challenge for established thoracic surgeons as it is a difficult technique to become skilled at with an protracted learning curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite freedom of movement with a two dimensional visualization of the operating field. Such a difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic anastomosis is needed.

Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot- assisted surgery offers some advantages including high- definition three- dimensional visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling, and tremor filtration, allowing the surgeon to perform complex operations comfortably in the domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim of this study was to investigate the short- term and long-term outcomes of RAILE to identify any clinical or oncologic benefits of RAILE in esophageal cancer.

研究概览

地位

主动，不招人

条件

详细说明

This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.

研究类型

观察性的

注册 (实际的)

51

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Shanghai、中国、200000
        • Yajie Zhang

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease.

描述

Inclusion Criteria:

  1. Patients with histologically proven esophageal malignancy
  2. All patients were within the American Society of Anesthesiologists (ASA) class I to III
  3. neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease

Exclusion Criteria:

Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
大体时间
rate of major postoperative complications
大体时间：30 days after surgery
30 days after surgery

次要结果测量

结果测量
大体时间
rate of overall postoperative complications
大体时间：30 days after surgery
30 days after surgery
rate of 30-day mortality
大体时间：30 days after surgery
30 days after surgery
operative time
大体时间：during the operation
during the operation
rate of conversion
大体时间：during the operation
during the operation
length of hospital stay
大体时间：within 30 days after surgery
within 30 days after surgery
rate of R0 resection
大体时间：within 30 days after surgery
within 30 days after surgery
number of harvested lymph nodes
大体时间：within 30 days after surgery
within 30 days after surgery
overall survival
大体时间：3 years after surgery
3 years after surgery
disease-free survival
大体时间：3 years after surgery
3 years after surgery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ruijin Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年6月14日

初级完成 (实际的)

2019年7月10日

研究完成 (预期的)

2024年4月4日

研究注册日期

首次提交

2017年5月2日

首先提交符合 QC 标准的

2017年5月2日

首次发布 (实际的)

2017年5月4日

研究记录更新

最后更新发布 (实际的)

2022年1月19日

上次提交的符合 QC 标准的更新

2022年1月3日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RTS-003

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Sweden

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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