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

NCT01654770 | Completed Phase 4

• 1 other identifier: SA-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overt Obscure Gastrointestinal Bleeding

Keywords

VCE, DBE,OGIB; consecutive; patients

Outcome Measures

Primary Outcomes (1)

• detection rate of bleeding cause

  1 day

Secondary Outcomes (1)

• rebleeding rate

  one year

Study Arms (2)

video capsule endoscopy

ACTIVE COMPARATOR

Video capsule endoscopy is performed every recruited patient.

Device: video capsule endoscopy

double balloon enteroscopy

ACTIVE COMPARATOR

Double balloon enteroscopy is performed after video capsule endoscopy in every recruited patient. (Tandem study)

Device: double balloon enteroscopy

Interventions

video capsule endoscopy DEVICE

video capsule endoscopy

double balloon enteroscopy DEVICE

double balloon enteroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• King Chulalongkorn Memorial Hospital: lead

Study Sites (1)

Gastroenterology Unit, King Chulalongkorn Memorial Hospital

Patumwan, Bangkok, 10330, Thailand

Location

Related Publications (1)

• Aniwan S, Viriyautsahakul V, Angsuwatcharakon P, Kongkam P, Treeprasertsuk S, Rerknimitr R, Kullavanijaya P. Comparison of urgent video capsule endoscopy and urgent double-balloon endoscopy in massive obscure gastrointestinal bleeding. Hepatogastroenterology. 2014 Oct;61(135):1990-4.

  PMID: 25713900 DERIVED

MeSH Terms

Interventions

Capsule Endoscopy; Double-Balloon Enteroscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Balloon Enteroscopy; Diagnostic Techniques, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Vichai Viriyatsahakul, MD, MSc

  Gastroenterology unit, King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

TH (1)