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

Not Applicable

Completed

• Conditions: Gastrointestinal Hemorrhage
• Interventions: Procedure: capsule endoscopy; Procedure: Mesenteric Angiogram

• Registration Number: NCT00153686
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Primary Completion: 2007-11
• Study Completion: 2008-03
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-09
• Last Update Posted: 2008-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capsule Endoscopy	capsule endoscopy	Capsule Endoscopy examination of small intestine
Mesenteric Angiogram	Mesenteric Angiogram	Mesenteric Angiogram of the small intestine

Primary Outcome Measures

Name	Time	Method
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.	12 months

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate	12 months

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong(SAR), China