Prospective Comparison of Air Contrast Barium Enema (ACBE), Computed Tomographic Colonography (Virtual Colonoscopy) and Colonoscopy for Evaluation of the Colon in Patients With Fecal Occult Blood
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 775
- 试验地点
- 28
研究概览
简要总结
RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. New diagnostic procedures such as computed tomographic colonography may provide a less invasive method of identifying patients who have colon cancer.
PURPOSE: Diagnostic and screening trial to compare the effectiveness of barium enema, computed tomographic colonography, and colonoscopy in detecting of colon cancer.
详细描述
OBJECTIVES:
- Compare the accuracy of air contrast barium enema, computed tomographic colonography (virtual colonoscopy), and colonoscopy for the detection of colonic lesions in patients with factors related to colon cancer.
- Compare the patient experience during each of these imaging tests.
OUTLINE: This is a multicenter study.
A repeat fecal occult blood test is performed. Patients then undergo an air contrast barium enema (ACBE). At 7-10 days after ACBE, patients undergo a computed tomographic colonography (virtual colonoscopy) followed by a colonoscopy on the same day.
A repeat ACBE may be performed if there is a discrepancy between the initial ACBE and colonoscopy. If the repeat ACBE continues to show an abnormality, patients undergo a second colonoscopy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •One of the following must be present:
- •At least 1 positive fecal occult blood test within the past 6 months
- •Iron deficiency anemia, defined as:
- •Hemoglobin less than 13 g/dL (males)
- •Hemoglobin less than 12 g/dL (females)
- •Ferritin less than 45 g/dL
- •Episode of bright red blood per the rectum
- •Family history of colon cancer or adenoma
- •One first-degree relative diagnosed with colon cancer or adenoma at age 60 or under OR
- •Two first-degree relatives diagnosed with colon cancer or adenoma at any age
- •No active gastrointestinal hemorrhage, including any of the following:
- •Reported or witnessed hematemesis
- •Melenic stools
- •Melenemesis
- •Multiple episodes of hematochezia within the past 2 months
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •See Disease Characteristics
- •Not specified
- •Not specified
- •Cardiovascular:
- •No myocardial infarction or cerebrovascular accident within the past 6 weeks
- •No respiratory failure within the past 6 weeks
- •No serious medical disorder (e.g., sepsis) within the past 6 weeks
- •Weight less than 300 pounds
- •Willing and able to undergo endoscopic or radiologic procedures
- •No need for special precautions in performing endoscopic procedures (e.g., antibiotic prophylaxis or complicated anticoagulation reversal)
- •No prisoners
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •No other concurrent clinical trial participation involving drugs, medical devices, and/or biologics
排除标准
- 未提供