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临床试验/NCT04288882
NCT04288882Unknown不适用

Role of Balloon-Assisted Enteroscopy (BAE) in Diagnosis and Treatment of Small Intestinal Disorders

Assiut University0 个研究点目标入组 80 人开始时间: 2020年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
主要终点
Role of Balloon-Assisted Enteroscopy (BAE) in Diagnosis and Treatment of Small Intestinal Disorders

研究概览

简要总结

Overall Aim:

This study is designed to assess the role of ballon-assisted enteroscopy in the management of obscure small intestinal disorders in a tertiary-care center in Upper Eygpt.

Specific objectives:

  1. Evaluate the technical success rate and causes of the procedure in our locality
  2. Explore the value and safety of BAE in the diagnose and treatment of suspected small bowel diseases.
  3. Assess patients' and endoscopists' satisfaction related to the procedure.
  4. Define the indications, diagnostic yield and appropriatness of BAE in our center.
  5. Determine the value of enteroscopy-obtained biopsy samples in the diagnosis.
  6. Perform a cost analysis of BAE in relation to its diagnostic value/yield.
  7. Report the therapeutic role of BAE in different small intestinal disorders.

详细描述

The small intestine is very essential for digestion and absorption and is presented between the stomach and large intestine. Because of its anatomical position, the small intestine was named as a "blind area" leading to difficulty in diagnosis of small bowel disease. The advant of ballon-assisted enteroscopy facilitates the management of the small bowel diseases. There are several causes of obscure small intestinal disorders, which are Angioectasia (20-55%), small bowel tumours (10-20%), Cameron erosions (5-15%), NSAID enteropathy (5%), Dieulafoy lesion (2-3%), Crohn's disease (2-10%), Coeliac disease( 2-5 %), Meckel's diverticulum (2-5%), duodenal varices (1-5%), gastric antral vascular ectasia (GAVE) (1-2%), Ectopic varices (1-2%), Portal hypertensive enteropathy 1-2% (but 60-70% in those with portal hypertension), Radiation enteritis (<1% ). Obscure gastrointestinal bleeding (OGIB) was the most common indication for enteroscopry and is defined as a bleeding from an unknown site after a negative evaluation of the GI tract with esophagogastroduodenoscopy (EGD) and ileocolonoscopy. OGIB represents about 5% of patients presenting with GI bleeding. OGIB isthe most common indication for enteroscopry, whatever the age groups, but the proportion of patients performing enteroscopy for OGIB was higher in elderly patients. Young patients were indicated for enteroscopy for other complains, such as abdominal pain, or suspicious small-bowel tumor. Egyptian study was done and identified that the source of OGIB in the small intestine represents 69.2%, with negative DBE findings in 30.8% and the most common lesions were angioectasias followed by GI tumours (30.8%, 19.2%, respectively).

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All male and female patients aged ≥18 - ≤80 year-old with suspected small intestinal disorders referred to the above Unit for BAE in the period between March 2020 till March 2022 inclusive irrespective of indication will be included in this study.

排除标准

  • Those who are <18 years-old and >80 years-old, those with gastrointestinal obstruction, preganat ladies, and those who fail to provide consent will be excluded.

结局指标

主要结局

Role of Balloon-Assisted Enteroscopy (BAE) in Diagnosis and Treatment of Small Intestinal Disorders

时间窗: baseline

This study is designed to assess the role of ballon-assisted enteroscopy in the management of obscure small intestinal disorders in a tertiary-care center in Upper Eygpt.

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

Amira Mohammed Abdel Mowgod

Doctor

Assiut University

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