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

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

Detailed Description
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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.

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

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Procedure: capsule endoscopy
* Procedure: Mesenteric Angiogram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capsule Endoscopy<br>Capsule Endoscopy examination of small intestine | Procedure: capsule endoscopy<br>* capsule endoscopy of small intestine<br>|
| Other: Mesenteric Angiogram<br>Mesenteric Angiogram of the small intestine | Procedure: Mesenteric Angiogram<br>* Mesenteric Angiogram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capsule Endoscopy, Mesenteric angiogram