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临床试验/NCT02826993
NCT02826993已完成不适用

Can Colon Capsule Endoscopy Substitute CT Colonography in the Large Bowel Examination of Persons Whose Colonoscopy Was Incomplete?

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Sensitivity and specificity of CCE compared to CTC

研究概览

简要总结

A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island. Between 5% and 10% of those are incomplete due to excessive pain, fixed colon loops, and other reasons. The current standard procedure is to refer the patient to the department of radiology for a CT-colonography. In some instances the radiology department can offer the investigation the next day, and thus in the same colon preparation. At other times they cannot, and the patient has to go through an second colon preparation for the colonography.

A CCE procedure could be provided to the participants immediately after the failed colonoscopy and the investigation can be completed the next morning in the same bowel preparation without a visit to the radiology department.

详细描述

Optical colonoscopy is the standard method for evaluating the colon. This technique allows evaluation of the entire colon in most patients. Full colonoscopy including examination of the cecum is associated with an increased detection rate of advanced neoplasia, as 33-50% of advanced neoplasia is located in the proximal colon. After an incomplete optical colonoscopy, participants are required to undergo another test in order to exclude clinically relevant lesions to reduce the risk of proximal cancer which has been shown to increase by twofold when colonoscopy was incomplete.

Endoscopic and radiological options to complete the colon assessment have been available in the last decades. Multiple alternative endoscopic techniques-such as colonoscopy with thinner colonoscopes, gastroscopes and device-assisted enteroscopes have been described. However, none of them has been clearly standardized.

CT colonography (CTC), is a relatively new imaging technique that was first described in 1994. In large randomized trials on symptomatic patients, CTC has been shown to be as equally effective as colonoscopy - for the detection of large colorectal polyps and already developed colorectal cancer.

Colon Capsule Endoscopy (CCE) is a promising new technology that may have the potential to complement existing diagnostic methods to screen people for colorectal cancer. Delivered correctly, it may reduce costs, increase utilization of medical services, reduce risks for patients and overall improve screening rates among the population.

A total of 8000 colonoscopies are performed on a yearly basis on the Funen Island and about 10% of those are incomplete due to excessive pain, fixed colon loops, and others causes. The current standard procedure is to refer the participant to the Department of Radiology for a CT-colonography.

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

性别
All
接受健康志愿者

入选标准

  • Incomplete colonoscopy

排除标准

  • Previous gastrointestinal surgery except for appendectomy
  • Known inflammatory bowel disease including Crohn's disease and ulcerative colitis
  • An ostomy
  • Symptoms on bowel obstruction
  • Pacemakers
  • Kidney diseases

结局指标

主要结局

Sensitivity and specificity of CCE compared to CTC

时间窗: Up to 14 days for conducting both procedures

The sensitivity and specificity of CCE will be measured in terms of n of polyps detected by CCE compared to n of polyps detected by CTC

次要结局

  • Polyp miss rate(Up to 30 days for conducting all three procedures)
  • Size estimation(Up to 14 days for conducting both procedures)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Morten Kobaek-Larsen

Project Coordinator

Odense University Hospital

研究点 (2)

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