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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00153686

Enrollment

Registered

2005-09-12

Start date

2005-06-30

Completion date

2008-03-31

Last updated

2008-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage

Keywords

Capsule Endoscopy, Mesenteric angiogram

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.

Interventions

PROCEDUREcapsule endoscopy

capsule endoscopy of small intestine

PROCEDUREMesenteric Angiogram

Mesenteric Angiogram

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.	12 months

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026