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Endoscopic Resection Multicenter Registry

2017年4月21日 更新者:Michel Kahaleh、Weill Medical College of Cornell University

Endoscopic Resection: A Retrospective and Prospective Multicenter Registry

This is a retrospective and prospective multicenter registry to collect long-term data (1 year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER, etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the tract wall.

Subjects will be consented for medical chart review.

The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).

The registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this registry study.

研究概览

详细说明

Endoscopic resection can be an appropriate approach in early neoplasms, challenging adenomas or sub-epithelial lesions. Endoscopic resection can be considered as a less invasive approach than surgery. Moreover, endoscopic resection can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.

The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection, and EFTR (Endoscopic full-thickness resection). Clinical metrics will be recorded including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.

Currently, there is limited multi-center data on endoscopic resection outcomes in western populations.

Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at WCMC-NYPH.

The purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).

研究类型

观察性的

注册 (预期的)

200

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

    • New York
      • New York、New York、美国、10065
        • 招聘中
        • Weill Cornell Medical College

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 及以上 (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

非概率样本

研究人群

Subjects undergoing Endoscopic resection procedures as part of their clinically indicated care

描述

Inclusion Criteria:

  • Any patient who is considering undergoing endoscopic resection within 6 months, or has undergone clinically indicated endoscopic resection within the past 6 months
  • Above or equal to 18 years of age.

Exclusion Criteria:

  • Any patient who has not undergone or will undergo endoscopic resection
  • Below 18 years of age.

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

队列和干预

团体/队列
干预/治疗
Endoscopic Resection
Patients undergoing Endoscopic Resection
Any Endoscopic resection for Gastrointestinal disorders including neoplasms.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of participants with reduction in clinical symptoms
大体时间:6 months from procedure
To assess resolution of symptoms of all Endoscopic resection procedures at 6 months
6 months from procedure

次要结果测量

结果测量
措施说明
大体时间
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
大体时间:30 days post procedure
Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure
30 days post procedure

其他结果措施

结果测量
措施说明
大体时间
Number of participants with successful completion of treatment
大体时间:30 days post procedure
Number of participants with successful completion of treatment
30 days post procedure

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。

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3月15日

初级完成 (预期的)

2020年3月1日

研究完成 (预期的)

2020年4月1日

研究注册日期

首次提交

2017年2月16日

首先提交符合 QC 标准的

2017年2月22日

首次发布 (实际的)

2017年2月27日

研究记录更新

最后更新发布 (实际的)

2017年4月25日

上次提交的符合 QC 标准的更新

2017年4月21日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

No IPD Sharing

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.

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