A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Satimai Aniwan, M.D., King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01654770
First received: July 30, 2012
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

Overt obscure gastrointestinal bleeding (OGIB) is a distinct clinical entity with significantly worse outcomes compared with colonic bleeding and upper GI bleeding. The mortality rate for patients with acute small bowel bleeding was 10%.1 Recently, a meta-analysis of 10 studies showed that VCE and DBE have an equivalent diagnosis yields in patients with obscure GIB (62% for VCE and 56% for DBE).2 The limitation of this meta-analysis study was that the included studies examined patients with occult OGIB and overt OGIB. Comparing with occult OGIB, patients with overt OGIB are more likely to present a significant lesion that causes a recurrent bleeding which subsequently increases risk of morbidity and mortality.3 According to emergency endoscopy concept from upper and lower GIB, patients with overt OGIB have been demonstrated the usefulness of urgent VCE and urgent DBE in a diagnosis tool with an impact on clinical management.4-7 Although previous studies showed promising data about the use of urgent enteroscopy, the debate about using VCE or DBE first in patients with massive overt OGIB is still uncertain. Thus in this study, we conducted the prospective study to compare urgent VCE with urgent DBE in patients with massive overt OGIB.


Condition Intervention Phase
Overt Obscure Gastrointestinal Bleeding
Device: video capsule endoscopy
Device: double balloon enteroscopy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Study Comparing Urgent Video Capsule Endoscopy With Urgent Double-balloon Enteroscopy in Patients With Massive Overt Obscure Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by King Chulalongkorn Memorial Hospital:

Primary Outcome Measures:
  • detection rate of bleeding cause [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rebleeding rate [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: video capsule endoscopy
Video capsule endoscopy is performed every recruited patient.
Device: video capsule endoscopy
Active Comparator: double balloon enteroscopy
Double balloon enteroscopy is performed after video capsule endoscopy in every recruited patient. (Tandem study)
Device: double balloon enteroscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The consecutive patients with massive overt OGIB defined as a visible gastrointestinal bleeding (GIB) (eg, melena or hemotochezia) of unknown origin that persists after an initial negative esophagogastroduodenoscopy (EGD) and colonoscopy were recruited. Massive was defined as the need for at least 3 units of blood transfusion. All patients underwent an EGD and colonoscopy within the first 48 hrs of hospitalization.

Exclusion Criteria:

  • Exclusion Criteria pregnancy, patients with a suspected intestinal obstruction or stricture, cardiac pacemaker implantation or other electromedical device implantation, diabetic gastroparesis, a history of gastrectomy and small bowel surgery.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01654770

Locations
Thailand
Gastroenterology Unit, King Chulalongkorn Memorial Hospital
Patumwan, Bangkok, Thailand, 10330
Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Investigators
Principal Investigator: Vichai Viriyatsahakul, MD, MSc Gastroenterology unit, King Chulalongkorn Memorial Hospital
  More Information

No publications provided

Responsible Party: Satimai Aniwan, M.D., Principal investigator, King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT01654770     History of Changes
Other Study ID Numbers: SA-001
Study First Received: July 30, 2012
Last Updated: July 31, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by King Chulalongkorn Memorial Hospital:
VCE, DBE,OGIB
consecutive
patients

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2014