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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00153686
Other study ID # CE_Ang
Secondary ID
Status Completed
Phase N/A
First received September 8, 2005
Last updated May 9, 2008
Start date June 2005
Est. completion date March 2008

Study information

Verified date May 2008
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date March 2008
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
capsule endoscopy
capsule endoscopy of small intestine
Mesenteric Angiogram
Mesenteric Angiogram

Locations

Country Name City State
China Endoscopy Center, Prince of Wales Hospital Hong Kong(SAR)

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy. 12 months No
Secondary 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 No
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