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

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00153686

Purpose

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

Condition	Intervention
Gastrointestinal Hemorrhage	Procedure: capsule endoscopy Procedure: Mesenteric Angiogram

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Gastrointestinal Bleeding

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	58
Study Start Date:	June 2005
Study Completion Date:	March 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Capsule Endoscopy: Experimental Capsule Endoscopy examination of small intestine	Procedure: capsule endoscopy capsule endoscopy of small intestine
Mesenteric Angiogram Mesenteric Angiogram of the small intestine	Procedure: Mesenteric Angiogram Mesenteric Angiogram

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153686

Locations

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

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

Wai K Leung, MD

CUHK

More Information

No publications provided

Responsible Party:	Chinese University of Hong Kong ( WK Leung )
Study ID Numbers:	CE_Ang
Study First Received:	September 8, 2005
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00153686 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

Capsule Endoscopy
Mesenteric angiogram

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Hemorrhage

ClinicalTrials.gov processed this record on August 30, 2009