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Evaluation the Performance of Given Diagnostic System in Detection of Bleeding Events in the Small Bowel

2013年3月4日 更新者:Francis KL Chan、Chinese University of Hong Kong

Evaluation the Performance of Given Diagnostic System in Detection of Bleeding Events in the Small Bowel: a Single-arm Prospective Cohort Study.

Obscure gastrointestinal bleeding (OGIB) has been one of the most challenging area in the field of gastroenterology, as small bowel is beyond the reach of ordinary endoscopes like oesophagogastroduodenoscopy (OGD) and colonoscopy. Thanks for the latest technological advancement for investigating small intestine, we are now capable of obtaining intraluminal images safely through capsule endoscopy (CE). Its role in obscure gastrointestinal bleeding, Crohn's disease and other small bowel pathologies has already been proven, and nowadays it is suggested by various authorities to be the first-line modality among all small bowel investigations.

The investigators group has showed that CE can alter the clinical management of patients with OGIB - patients with negative CE has lower rebleeding rate, and therefore we may adopt a conservative approach for them. Although supported by some other group as well, conflicting results were still reported in the literature about the out-come of these patients. The main criticisms for these studies are that, CE can only identify 61% of the underlying small bowel bleeding pathology, and one can never ascertain the outcome of patients with negative CE examination. Apparently there is still room for improvement in the current CE technology.

研究概览

地位

终止

干预/治疗

详细说明

Newer generation of CE (PillCam ColonTM) has been developed to investigate the large bowel. It is different from small bowel CE that it consists of two cameras at both ends of the capsule, so as to enhance the coverage of colonic mucosa visualization. An improved generation of this colon capsule, named PillCam Colon 2TM, is also in its developmental phase. With the new "adaptive frame rate" (AFR) technology, the CE optimizes the visual coverage of the bowel by increasing the frame rate up to 35 frames per second when the capsule is moving quickly in certain areas, while decreasing the frame rate down to 4 frames per second when the capsule is moving slowly or remains stationary so as to conserve the battery life. Preliminary data from colorectal cancer screening has shown that it could improve the diagnostic yield of colonic polyps.

The investigators hypothesize that, by re-programming the PillCam Colon 2TM so as to initiate AFR since ingestion, it could improve the visualization of small intestinal lumen and hence improves the sensitivity of small bowel CE examination.

研究类型

介入性

注册 (实际的)

6

阶段

  • 阶段2
  • 第三阶段

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

      • Hong Kong、中国
        • Prince of Wales Hospital

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

描述

Inclusion Criteria:

  1. Patients with overt GI bleeding (hematemesis, coffee-grounds, rectal bleeding and/or melena) with negative OGD but not critically ill, who should read positive on small bowel investigation (SBI)
  2. Patients with occult GI bleeding (Faecal occult blood test,FOBT +)
  3. Patients with suspected arteriovenous(AV) malformations.
  4. Patients treated with nonsteroidal antiinflammatory drugs (NSAIDs)
  5. Patients with active Crohn's disease(CD), with no evidence of obstruction

Exclusion Criteria:

  1. In patients with known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-ingestion testing and profile.
  2. In patients with cardiac pacemakers or other implanted electromedical devices.
  3. In patients with dysphagia or other swallowing disorders.
  4. Unable to obtain informed written consent

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
实验性的:Colon 2
using Colon 2 capsule in detecting bleeding events in small bowel
Ingest one colon 2 capsule
其他名称:
  • C2

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
Diagnostic yield for bleeding events in the small bowel
大体时间:1 year
Review the capsule video to detect the bleeding events.
1 year

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。

调查人员

  • 首席研究员:Joseph JY Sung, MD、CUHK

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

2011年1月1日

初级完成 (实际的)

2012年1月1日

研究完成 (实际的)

2012年1月1日

研究注册日期

首次提交

2011年8月2日

首先提交符合 QC 标准的

2011年9月26日

首次发布 (估计)

2011年9月27日

研究记录更新

最后更新发布 (估计)

2013年3月5日

上次提交的符合 QC 标准的更新

2013年3月4日

最后验证

2013年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • C2 in SB

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