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临床试验/NCT03667950
NCT03667950Unknown不适用

Vascular Border Zone Definition Using Intraoperative Hyperspectral Imaging for Resections and Reconstructions in Diseases of the Esophagus, Stomach, Pancreas, Small Intestine, Large Intestine and Rectum to Optimize Anastomotic Healing

University of Leipzig2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Anastomotic Perfusion: Tissue-Water-Index

研究概览

简要总结

In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.

详细描述

The anastomoses were examined under standardized conditions directly after creation. The measurements were performed like described before, using the TIVITA Tissue system (Diaspective Vision GmbH, Am Salzhaff, Germany). This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). The distance between camera and object was 30 cm for all measurements. The Number of Effective Pixels at this distance is 640 × 480 (x-, y-axis. The resulting field of view (FOV) has the dimensions 6.4 × 4.8 cm2 and a spatial resolution of 0.1 mm/pixel. The FOV is illuminated by 8 halogen spots (20 W each). The ceiling lights and other light sources were switched off, to avoid artifacts during the measurement (approximately 10 seconds). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. This work is focused on tissue oxygenation (StO2), which represents the relative blood oxygenation in the microcirculation of superficial tissue layers (approximately 1 mm) and the near-infrared (NIR) Perfusion Index, representing tissue layers in 4-6 mm penetration depth.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all gastrointestinal anastomoses

排除标准

  • inability to consent

研究组 & 干预措施

hyperspectral imaging

Experimental

diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures

干预措施: Hyperspectral Imaging (Procedure)

结局指标

主要结局

Anastomotic Perfusion: Tissue-Water-Index

时间窗: direct during the Operation (ca. 15-20 Minutes)

Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)

Anastomotic Perfusion: Near Infrared Perfusion Index

时间窗: direct during the Operation (ca. 15-20 Minutes)

Near Infrared Perfusion Index in %: Relative O2 saturation of the blood immicrocircular system in deeper tissue layers (penetration depth: 4-6mm; index value)

Anastomotic Perfusion: Tissue-Hemoglobin index

时间窗: direct during the Operation (ca. 15-20 Minutes)

Tissue Hemoglobin index in %: Existing hemoglobin distribution in the microcircular system of the tissue area under consideration (index value)

Anastomotic Perfusion: (Oxygenation (StO2)

时间窗: direct during the Operation (ca. 15-20 Minutes)

Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm)

次要结局

未报告次要终点

研究者

发起方
University of Leipzig
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Boris Jansen-Winkeln

Dr.

University of Leipzig

研究点 (2)

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