此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy (ATTR2026)

2026年6月8日 更新者:Clinique Saint Jean, France

Assessment of Diagnostic Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy in Patients Who Underwent Endoscopic Carpal Tunnel Syndrome Surgery

Transthyretin amyloidosis (ATTR) is an underdiagnosed condition that can present early as carpal tunnel syndrome, sometimes preceding cardiac involvement by several years. The recent emergence of new treatments underscores the importance of early diagnosis. Synovial biopsy performed during open carpal tunnel surgery is considered the gold standard for local screening, but it is less accessible, more difficult, and riskier to perform via endoscopy-a minimally invasive surgical technique that is currently the standard at our center and is becoming increasingly widespread.

The anterior annular ligament of the carpus constitutes an alternative tissue to the synovium, easily accessible via endoscopy, safe, and standardizable.

In this study, the systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during endoscopic carpal tunnel surgery would allow for the evaluation of the diagnostic concordance of the ligament biopsy by comparing it to the results obtained using the gold standard method. This strategy would also provide an opportunity to analyze the feasibility of systematic screening for ATTR on the ligament during endoscopic procedures.

This approach could offer a practical and innovative method for the early identification of at-risk patients and facilitate appropriate and timely management of the condition.

研究概览

研究类型

介入性

注册 (估计的)

500

阶段

  • 不适用

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。

学习联系方式

学习地点

      • Montpellier、法国、34430
        • 招聘中
        • Clinique St jean sud de france
        • 接触:

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult patient with Health Insurance
  • Clinical diagnosis + carpal tunnel EMG
  • Validated indication for carpal tunnel surgery
  • Signed informed consent
  • Patient at risk for postoperative complications (bilateral carpal tunnel syndrome, heart failure, atrial fibrillation, elderly patients)

Exclusion Criteria:

  • Need for open carpal tunnel surgery.
  • Pregnant women
  • Adults under guardianship

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

  • 主要用途:诊断
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Annular ligament biopsy in conjunction with a synovial biopsy
For all patients, systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during the surgery
In addition to the standard synovial biopsy, a biopsy of the annular ligament of the carpus will be performed during endoscopic carpal tunnel surgery

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
agreement between the gold standard and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery.
大体时间:up to 3 weeks
To assess the agreement between the gold standard (synovial biopsy) and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery.
up to 3 weeks

次要结果测量

结果测量
措施说明
大体时间
Assessment and description of the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery.
大体时间:Perioperative/Periprocedural
To evaluate and describe the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery. Feasibility will be assessed by the proportion of procedures in which a biopsy specimen of the anterior annular ligament of the carpus can be successfully obtained and submitted for histopathological analysis during endoscopic carpal tunnel surgery.
Perioperative/Periprocedural
Safety Assessment of Ligament Biopsy
大体时间:up to 24hours
Assess the safety of ligament biopsy, particularly with regard to specific complications.
up to 24hours

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)

2026年5月27日

初级完成 (估计的)

2027年5月27日

研究完成 (估计的)

2027年5月27日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年6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

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.

订阅