跳至主要内容
临床试验/NCT01654770
NCT01654770已完成4 期

A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy in Patients With Massive Overt Obscure Gastrointestinal Bleeding

King Chulalongkorn Memorial Hospital2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
27
试验地点
2
主要终点
detection rate of bleeding cause

研究概览

简要总结

Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this meta-analysis study was that the included studies examined patients with occult OGIB and overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a significant lesion that causes a recurrent bleeding which subsequently increases risk of morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB, patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE in a diagnosis tool with an impact on clinical management.4-7 Although previous studies showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE first in patients with massive overt OGIB is still uncertain. Thus in this study, we conducted the prospective study to compare urgent VCE with urgent DBE in patients with massive overt OGIB.

详细描述

Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this meta-analysis study was that the included studies examined patients with occult OGIB and overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a significant lesion that causes a recurrent bleeding which subsequently increases risk of morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB, patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE in a diagnosis tool with an impact on clinical management.4-7 Although previous studies showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE first in patients with massive overt OGIB is still uncertain. Thus in this study, we conducted the prospective study to compare urgent VCE with urgent DBE in patients with massive overt OGIB.

Objective The objective of this study was to compare the diagnostic yield between urgent VCE and urgent DBE in patients with massive overt OGIB.

Patients and Methods Patients Between October 2010 and March 2012, patients referred to a tertiary, King Memorial Chulalongkorn University Hospital to evaluate GIB. The consecutive patients with massive overt OGIB defined as a visible gastrointestinal bleeding (GIB) (eg, melena or hemotochezia) of unknown origin that persists after an initial negative esophagogastroduodenoscopy (EGD) and colonoscopy were recruited. Massive was defined as the need for at least 3 units of blood transfusion. All patients underwent an EGD and colonoscopy within the first 48 hrs of hospitalization. In case that the causes of gastrointestinal bleeding had not been identified, informed consent was obtained from all enrolled patients.

Exclusion criteria were pregnancy, patients with a suspected intestinal obstruction or stricture, cardiac pacemaker implantation or other electromedical device implantation, diabetic gastroparesis, a history of gastrectomy and small bowel surgery.

This study was a prospective study comparing between urgent VCE and urgent DBE. VCE and DBE were performed within the first 72 hrs of hospitalization. VCE was carried out 12 hrs before DBE. The independent operators performed VCE and DBE. The VCE results were blinded to the DBE endoscopists. A positive finding was considered that finding could explain the cause of bleeding and/or resulted in a correct therapeutic management including taking biopsy sampling. A negative finding was considered when the cause of bleeding was not detected and there was no recurrence of bleeding during the follow up period. The results of CE and DBE were evaluated whether or not the total small bowel was visualization. The diagnosis yield and the impact on clinical outcome were assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • The consecutive patients with massive overt OGIB defined as a visible gastrointestinal bleeding (GIB) (eg, melena or hemotochezia) of unknown origin that persists after an initial negative esophagogastroduodenoscopy (EGD) and colonoscopy were recruited. Massive was defined as the need for at least 3 units of blood transfusion. All patients underwent an EGD and colonoscopy within the first 48 hrs of hospitalization.

排除标准

  • Exclusion Criteria pregnancy, patients with a suspected intestinal obstruction or stricture, cardiac pacemaker implantation or other electromedical device implantation, diabetic gastroparesis, a history of gastrectomy and small bowel surgery.

结局指标

主要结局

detection rate of bleeding cause

时间窗: 1 day

次要结局

  • rebleeding rate(one year)

研究者

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

Satimai Aniwan, M.D.

Principal investigator

King Chulalongkorn Memorial Hospital

研究点 (2)

Loading locations...

相似试验