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

Gastrointestinal Hemorrhage Clinical Trial

Official title:

Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153686
• Other study ID #: CE_Ang
• 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

• Gastrointestinal Hemorrhage

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