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临床试验/NCT02341755
NCT02341755终止不适用

Dual Energy Computerized Tomography (DE-CT) for Evaluation of Obstructive Intestinallesions in Patients With Crohn's Disease

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
1
主要终点
Abdominal surgery

研究概览

简要总结

This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in predicting the need for surgery in patients with Crohn's disease and intestinal lesions with obstructive symptoms.

Patients with known Crohn's disease which were scheduled to perform abdominal CT for obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome of surgery. DE-CT parameters were then compared between patients who underwent surgery and those who did not.

详细描述

INTRODUCTION Intestinal strictures are common in patients with Crohn's (CD) disease and may result in intestinal obstruction. Current available imaging studies can usually identify and locate the stricture, but can not reliably differentiate the patients who will require surgery from those who will respond to medical therapy.

Dual Energy computerized tomography (DE-CT) uses two energy sources using high and low tube voltage, thus creating two data sets. Dedicated software creates overlay of the low and high energy images, in which enhancement of tissues with iodine can be better appreciated and quantified compared to standard CT. The investigators hypothesize that dual energy can better visualize the iodine uptake in bowl wall as a marker of inflammation within intestinal lesions, and may help in identifying the patients who will or will not require surgery.

AIM To evaluate the efficacy of DE-CT studies in predicting need for surgery within 3 months.

METHODS Patients with known CD undergoing abdominal CT for possible obstructive presentation prospectively underwent a DE-CT using intravenous iodinated contrast material, and were followed for 3 months for an outcome of surgery.

The DE-CT was interpreted by a radiologist blinded to the clinical outcome, and the attending physicians of the patients were blinded to the interpretation of the DE-CT. DE-CT parameters were then compared between patients who underwent surgery and those who did not. Receiver operating characteristic (ROC) curve analysis was used to find the optimal cut off point to distinguish between patients which did or did not eventually underwent surgery. Based on the cut off points found from the ROC analysis, the negative and positive predictive values were calculated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age over 18 years,
  • known Crohn's disease (at least 3 moths prior)
  • obstructive symptoms
  • scheduled for abdominal CT for evaluation of symptoms (regardless of participation in the study)

排除标准

  • Pregnancy
  • Contraindication to perform CT with IV contrast media

结局指标

主要结局

Abdominal surgery

时间窗: 3 months

次要结局

未报告次要终点

研究者

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

Tomer Adar

Senior physician in internal medicine, senior gastroenterologist

Shaare Zedek Medical Center

研究点 (1)

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