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NCT Number: NCT00153686

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

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

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Key information

Conditions

Gastrointestinal Hemorrhage Digestive System Diseases Gastrointestinal Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Endoscopy Center, Prince of Wales Hospital

Hong Kong(SAR), China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

capsule endoscopy

Procedure

capsule endoscopy of small intestine

Mesenteric Angiogram

Procedure

Mesenteric Angiogram

Primary outcomes

  1. Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.

    Time frame: 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
May 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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