Capsule Endoscopy vs. Push Enteroscopy in Occult Gastrointestinal Bleeding OGIB

NCT00224627 | Completed Phase 3 DMC

• 2 other identifiers: P040101CDT03002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Capsule endoscopy (CE) is a safe and effective tool for the assessment of obscure gastrointestinal bleeding (OGIB). However, its real efficacy and its position in the diagnostic algorithm of OGIB vs. push enteroscopy (PE) remain unknown since in previous studies both techniques were performed in all included patients The purpose of this protocol is to conduct a randomized prospective controlled trial in patients with OGIB comparing a strategy based on CE or PE followed by the alternative exploration only when the first line exploration was negative. The main outpoint of this study concerns the diagnostic yield of the two explorations. Second endpoint concerns the clinical relevance of the two strategies tested (CE ± PE vs. CE ± PE) in terms of diagnostic yield, clinical outcome, therapeutic impact and added explorations

Conditions

Occult Gastrointestinal Bleeding

Keywords

Randomized study; Capsule endoscopy; Push enteroscopy; Occult gastrointestinal bleeding; Endoscopy

Outcome Measures

Primary Outcomes (1)

• The primary end point was the diagnostic yield of CE and PE (first line exploration allocated by randomization) for the identification of a definitive source of bleeding.

Secondary Outcomes (1)

• Secondary end points were evaluated at the end of the follow up period and concerned the clinical relevance of the two strategies (PE ± CE vs. CE ± PE). They included: (1) the diagnostic yield of the two strategies for the identification of a definitive

Interventions

Capsule GIVEN IMAGING LTD PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Patients may suffer from episodes of active bleeding within the last 6 months or chronic iron-deficiency anemia (hemoglobin \< 10 g/dl).
• A gynecologic or proctologic bleeding source had to be excluded.
• All patients had to have negative workup including upper gastrointestinal endoscopy, colonoscopy and small-bowel barium series or computed tomography enteroclysis.
• Abdominal angiography was only performed when there were signs of active bleeding during the diagnostic work-up (n = 3). Meckel scintigraphy was usually carried out in patients under 30 years of age (n = 14).

You may not qualify if:

• Patient presenting a digestive bleeding with an echo hemodynamic major and\\or requiring urgent therapeutic measures
• Wait presenting a gynaecological cause or a cause proctology of sure imputability or syndrome of malabsorption or deficiency of contribution not formally excluded
• Patient presenting an occlusive syndrome or a hurt of stenosis hail objectivized by a radiological exploration
• Surrounding wall(Speaker) or in age waits to procreate without effective contraception
• The mental or physical state of the patient not allowing a maid compliance in the conditions of the try(essay) and or in the correct use of the device Patient carrier of a pacemaker or another electromechanical implant
• Patient that must undergo an examination by MRI before having been able to eliminate the capsule
• Enteroscopy or video capsule prerequisite technically satisfactory and in touch with same pathological episode or dating at least less than 6 months Patient participating at present in another clinical trial without direct profit which can directly or indirectly influence the results(profits) of the present study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• Adler DG, Knipschield M, Gostout C. A prospective comparison of capsule endoscopy and push enteroscopy in patients with GI bleeding of obscure origin. Gastrointest Endosc. 2004 Apr;59(4):492-8. doi: 10.1016/s0016-5107(03)02862-1.

  PMID: 15044884 BACKGROUND

Study Officials

• Raymond JIAN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 23, 2005
• Study Start: March 1, 2002
• Study Completion: June 1, 2005
• Last Updated: March 26, 2007

Record last verified: 2007-03

Locations

FR (1)