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临床试验/NCT03616041
NCT03616041招募中不适用

Video Capsule Endoscopy for Lesion Localization and Diagnosis in Patients With Severe Hematochezia

CURE Digestive Diseases Research Center2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
23
试验地点
2
主要终点
The diagnostic yield tests in detecting a bleeding site and comparison of rates

研究概览

简要总结

Patients with severe hematochezia (bright red blood per rectum) may have a bleeding source proximal to the colon. Visualization of the entire gastrointestinal tract using a second-generation colon capsule endoscopy system could improve diagnostic yields and form the basis for a new approach to early diagnosis that could change guidelines and practice management in these patients. The hypothesis of this study is that urgent colon capsule endoscopy will have higher rates of lesion localization and diagnosis and reduced time to diagnosis than the standard tagged red blood cell scanning and/or angiography. In this study, the eligible patients with severe hematochezia are enrolled to undergo an evaluation with the capsule endoscopy in addition to the standard tests including a tagged RBC scan and/or an angiogram. The outcomes in terms of diagnostic yields of the capsule endoscopy will be compared to the standard tests.

详细描述

Background and Significance

Currently there are no consensus guidelines for the best approach to patient with severe hematochezia. One strategy is to perform an urgent colonoscopy (following a colon purge) within 12-15 hours. Although this strategy has been associated with a decreased length of hospitalization and an improved diagnostic and therapeutic yields, it has drawbacks. A major disadvantage of performing an urgent colonoscopy is that the endoscopist can evaluate only the colon and the distal ileum, while more proximal sources of bleeding are not evaluated. Another limitation is that thorough cleansing of the colon is required to facilitate complete evaluation, identification of stigmata of recent hemorrhage and lesion diagnosis. Urgent colonoscopy is labor intense and relies on a dedicated bleeding team with expertise in both diagnosis and hemostasis. Another option for patients with persistent or recurrent hematochezia is to perform either a tagged RBC scan or an angiogram to identify the bleeding location. However, these techniques also have major disadvantages, including low diagnostic yields for severe hematochezia, requiring additional tests for diagnosis, and cannot visually detect non-bleeding stigmata of hemorrhage on lesions that can be seen during colonoscopy or by capsule endoscopy.

Research Design and Methods This is a study of patients who being admitted to the hospital for severe hematochezia or inpatients who developed hematochezia after hospitalization for an unrelated non-GI bleeding reason. Those who meet entry criteria and lack exclusions on screening before will being asked to participate in this study.

After informed consent, patients will be a colon preparation prior to ingestion of the colon capsule. The capsule recording system will be activated once patients swallow the capsule. Once the capsule has been excreted or if the capsule stops recording images (usually 10 hours after activation), the video recorder will then be taken to a workstation and the video will be downloaded for reading.

In addition to having the capsule endoscopy, all consented patients will undergo standard tests for the initial diagnosis and management of severe hematochezia: tagged RBC scan and/or computerized tomographic angiography (CTA), magnetic resonance imaging (MRI) angiogram, or conventional angiography. Because of contra indication, MRI angiography will not be performed until the capsule has been excreted, nor will CT angiography because the capsule may interfere with interpretation. All patients will also have urgent colonoscopy after clearing the colon of blood and stool with the purge. All of these diagnostic procedures will be performed within 48 hours of GI consultation, but ideally as soon as possible.

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

  • 18 years old or older
  • Able to provide written informed consent or have a legal surrogate who can provide written consent
  • Presenting with evidence of severe ongoing hematochezia (i.e. passage of red blood or clots per rectum witnessed by a health care provider) and have a decrease in hemoglobin from baseline of 2 or more grams and/or transfusion of 1 or more units of red blood cells for resuscitation with either outpatient or inpatient start of severe hematochezia.

排除标准

  • Uncooperative, unable to give written informed consent personally or through a legal surrogate, or refuse to participate
  • Contraindication to undergo capsule endoscopy due to:
  • Documented or suspected bowel obstruction (partial or complete)
  • Anatomical GI abnormalities such as strictures of the foregut or small bowel
  • Inability to swallow the capsule
  • Presence of cardiac pacemakers or other implanted electromedical devices
  • American Society of Anesthesiology (ASA) class V (very severe co-morbidities and very poor prognosis for surgery or similar procedures)
  • Very severe GI bleeding with shock not responsive to IV fluid resuscitation and/or transfusions and IV medications to raise the systolic blood pressure
  • History of recent hematemesis (within 30 days), positive nasogastric, or orogastric (OG) aspirate suggesting an upper GI bleed
  • Presenting with recurrent hematochezia that has been previously diagnosed as anorectal bleeding

结局指标

主要结局

The diagnostic yield tests in detecting a bleeding site and comparison of rates

时间窗: 30 days

The diagnostic yield of the bleeding site detection (defined as the rates of detection and percentage of positive results as eg. positive test or total tests) for capsule endoscopy, tagged red blood cell scan/angiography, and endoscopy will be calculated. Rates of positive detection will be compared by the McNemar test for data using exact methods.

次要结局

  • The sensitivity for lesion localization(30 days)
  • The specificity for lesion localization(30 days)
  • The accuracy for lesion localization(30 days)

研究者

发起方
CURE Digestive Diseases Research Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis M Jensen, M.D.

Professor of Medicine

CURE Digestive Diseases Research Center

研究点 (2)

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