Back to resultsCapsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin
Primary Purpose
Gastrointestinal Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
capsule endoscopy
Mesenteric Angiogram
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Hemorrhage focused on measuring Capsule Endoscopy, Mesenteric angiogram
Eligibility 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
Sites / Locations
- Endoscopy Center, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Capsule Endoscopy
Mesenteric Angiogram
Arm Description
Capsule Endoscopy examination of small intestine
Mesenteric Angiogram of the small intestine
Outcomes
Primary Outcome Measures
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
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
Full Information
NCT ID
NCT00153686
First Posted
September 8, 2005
Last Updated
May 9, 2008
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00153686
Brief Title
Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin
Official Title
Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage
Keywords
Capsule Endoscopy, Mesenteric angiogram
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capsule Endoscopy
Arm Type
Experimental
Arm Description
Capsule Endoscopy examination of small intestine
Arm Title
Mesenteric Angiogram
Arm Type
Other
Arm Description
Mesenteric Angiogram of the small intestine
Intervention Type
Procedure
Intervention Name(s)
capsule endoscopy
Intervention Description
capsule endoscopy of small intestine
Intervention Type
Procedure
Intervention Name(s)
Mesenteric Angiogram
Intervention Description
Mesenteric Angiogram
Primary Outcome Measure Information:
Title
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai K Leung, MD
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Center, Prince of Wales Hospital
City
Hong Kong(SAR)
Country
China
12. IPD Sharing Statement
Learn more about this trial
Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin
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