Diagnostic Accuracy of Capsule Endoscopy in Small Bowel Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Sensitivity, positive predictive value, and accuracy of capsule endoscopy, CT enterography, colonoscopy with ileoscopy, and small bowel follow through using a consensus clinical diagnosis of small bowel Crohn's disease as the reference standard.
研究概览
简要总结
Prospective study to compare in a blinded fashion four different diagnostic modalities to detect active small bowel Crohn's disease: a) colonoscopy with ileoscopy; b) small bowel follow through; c) capsule endoscopy; and d) computed tomography enterography.
详细描述
Aims:
The aims of this study are as follows: 1) to describe the spectrum of small intestinal lesions demonstrated by capsule endoscopy (CE) in patients with Crohn's disease; 2) to determine the inter-observer agreement for recognizing these small intestinal lesions; 3) to determine the sensitivity, positive predictive value, and accuracy of CE, CT enterography, small bowel follow-through, colonoscopy with ileoscopy, and all pairwise combinations of these examinations with a consensus clinical diagnosis for the diagnosis and evaluation of the extent and severity of small intestinal Crohn's disease; 4) to establish a Crohn's Disease Capsule Endoscopy Index of Severity (CDCEIS); 5) to describe the spectrum of right colon lesions demonstrated by CE in patients with Crohn's disease.
Study Design and Methods:
Consecutive adult patients with suspected or definite Crohn's disease seen in the Inflammatory Bowel Disease Clinic at Mayo Clinic Rochester will be offered enrollment in a prospective observational trial comparing CE with CT enterography, small bowel follow-through, colonoscopy, and a consensus clinical diagnosis of Crohn's disease. Seventy patients will be enrolled, according to the inclusion and exclusion criteria, and written informed consent will be obtained. Co-investigators in the Inflammatory Bowel Disease (IBD) Clinic will clinically evaluate all patients, including a history and limited physical examination. Patients will undergo clinically indicated laboratory tests. Serum will be stored on all patients for other potential laboratory studies. Patients will complete a retrospective symptom diary for the week prior to their evaluation at Mayo, and a Crohn's Disease Activity Index (CDAI) will be calculated.
All patients will have a CT enterography with peroral contrast interpreted by a co-investigator radiologist. All patients will undergo a clinically indicated colonoscopy with ileoscopy by a staff co-investigator (not by C.A.S. or the staff co-investigator interpreting the CE), and a Crohn's Disease Endoscopic Index of Severity (CDEIS) will be calculated. If no significant small bowel strictures are identified by CT enterography or colonoscopy with ileoscopy, then patients will subsequently undergo CE. All CE studies will be read separately by C.A.S. (gastroenterology fellow) and a supervising staff gastroenterologist co-investigator, each blinded to the other's interpretation. The interobserver agreement between C.A.S. and the co-investigator staff will be determined. Patients will lastly have a clinically indicated small bowel follow-through interpreted by a co-investigator radiologist. All co-investigators will be blinded to the results of the other imaging modalities until after interpreting their respective studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient of either sex aged 18 to 70 years
- •Patient has suspected or definite Crohn's disease
- •Patient has read, understood, and signed a written informed consent form at visit 1.
排除标准
- •Pregnancy
- •Patients who are prisoners, institutionalized individuals, or vulnerable adults
- •Patients immediately in need of abdominal surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, perforation, or intra-abdominal abscess
- •Patients with known or suspected gastrointestinal obstruction due to significant stricture based upon the clinical symptoms (nausea, vomiting, abdominal distention, or abdominal pain) confirmed by pre-procedure evaluation. Pre-procedure evaluation includes CT enterography or small bowel follow through performed at Mayo or previously at an outside institution which demonstrates mechanical obstruction (mechanical obstruction defined as small bowel narrowing with pre-stenotic dilatation); additionally, a high-grade stenotic ileocecal valve or ileocolonic anastomosis found by colonoscopy.
- •Patients with history of abdominal radiation
- •Patients with known or suspected oropharyngeal or esophageal dysphagia (unless recent EGD shows no evidence of mechanical obstruction of the esophagus, in cases of esophageal dysphagia)
- •Patients with pacemakers or other implantable electromedical devices
- •Patients with highly suspected or documented gastroparesis
- •Patients who have used NSAIDs within the previous 2 weeks
- •Patients with an anticipated need for an MRI scan within two weeks after M2A capsule ingestion (for patients who require a clinically indicated MRI, the MRI should be performed prior to administration of the M2A capsule)
- •Patients with a creatinine ≥ 2.
- •Patients with documented reaction to iodinated contrast material.
- •Patients with an ileostomy or colostomy
- •Patients with documented reaction to metoclopramide.
- •Patients with a hemoglobin less than 7.5 g/dl. (Patients with Crohn's disease are often chronically anemic, and a hemoglobin of 7.5 g/dl or greater would allow these patients to safely participate in the study.)
研究组 & 干预措施
1
All patients were to undergo all 4 diagnostic modalities, and each of these was compared to the consensus clinical diagnosis. Readers of each modality were blinded to the results of the other 3.
干预措施: Capsule endoscopy, CT enterography, colonoscopy, small bowel follow-through (Device)
结局指标
主要结局
Sensitivity, positive predictive value, and accuracy of capsule endoscopy, CT enterography, colonoscopy with ileoscopy, and small bowel follow through using a consensus clinical diagnosis of small bowel Crohn's disease as the reference standard.
次要结局
- Describe spectrum of right colon lesions visualized by capsule endoscopy in patients with Crohn's disease.