Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00153686
First received: September 8, 2005
Last updated: May 9, 2008
Last verified: May 2008
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study

Resource links provided by NLM:

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

Keywords provided by Chinese University of Hong Kong:
Capsule Endoscopy
Mesenteric angiogram

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013