Emergency Capsule Endoscopy in Severe GI-bleeding

Phase 2

Completed

• Conditions: GI-bleeding
• Interventions: Device: capsule endoscopy

• Registration Number: NCT01584869
• Lead Sponsor: Technical University of Munich

Brief Summary

Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-25
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-28
• Last Update Posted: 2015-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

patients with signs of severe GI-bleeding (with melena or dark bloody stool) and hemodynamic instability (defined as (pre)collapse or MAP < 80 mmHg or HR > 110) and/or drop of hemoglobin > 2g/dl/d and/or need of transfusion of minimum of 2 packed red cells

Exclusion Criteria

missing consent form, pregnancy, origin of bleeding found in upper GI-endoscopy (e.g. blood in the stomach, ulcer, varices with signs of bleeding, mallory-weiss-tear, Angiodysplasia (with signs of bleeding), refluxesophagitis LA C or D) fresh bloody stool, known stenosis of the bowel, known site of bleeding, known inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
capsule endoscopy	capsule endoscopy	-

Primary Outcome Measures

Name	Time	Method
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.	after complete recruitment

Secondary Outcome Measures

Name	Time	Method
frequency of mid-GI-bleeding in all patients
diagnostic yield	after complete recruitment

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 München, Bavaria, Germany