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Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin

NCT ID: NCT00153686

Last Updated: 2008-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-03-31

Brief Summary

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To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.

Detailed Description

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Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.

Conditions

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Gastrointestinal Hemorrhage

Keywords

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Capsule Endoscopy Mesenteric angiogram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Capsule Endoscopy

Capsule Endoscopy examination of small intestine

Group Type EXPERIMENTAL

capsule endoscopy

Intervention Type PROCEDURE

capsule endoscopy of small intestine

Mesenteric Angiogram

Mesenteric Angiogram of the small intestine

Group Type OTHER

Mesenteric Angiogram

Intervention Type PROCEDURE

Mesenteric Angiogram

Interventions

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capsule endoscopy

capsule endoscopy of small intestine

Intervention Type PROCEDURE

Mesenteric Angiogram

Mesenteric Angiogram

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
* Normal or non-diagnostic OGD and colonoscopy
* Informed consent
* Patients presented with shock will be resuscitated for urgent endoscopy

Exclusion Criteria

* Patients remained in shock despite resuscitation.
* Moribund patients
* Terminal malignancy
* Presence of pacemaker or ICD
* Suspected or confirmed intestinal obstruction
* Swallowing difficulties
* Renal failure that preclude angiographic examination
* Pregnancy
* Age \<18
* Refused consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chinese University of Hong Kong

Principal Investigators

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Wai K Leung, MD

Role: PRINCIPAL_INVESTIGATOR

CUHK

Locations

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Endoscopy Center, Prince of Wales Hospital

Hong Kong(SAR), , China

Site Status

Countries

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China

Other Identifiers

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CE_Ang

Identifier Type: -

Identifier Source: org_study_id