Back to resultsEmergency Capsule Endoscopy in Severe GI-bleeding
Primary Purpose
GI-bleeding
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
capsule endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for GI-bleeding focused on measuring GI-bleeding, capsule endoscopy
Eligibility Criteria
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
Sites / Locations
- Klinikum rechts der Isar
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
capsule endoscopy
Arm Description
Outcomes
Primary Outcome Measures
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.
Secondary Outcome Measures
frequency of mid-GI-bleeding in all patients
diagnostic yield
Full Information
NCT ID
NCT01584869
First Posted
April 23, 2012
Last Updated
January 28, 2015
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT01584869
Brief Title
Emergency Capsule Endoscopy in Severe GI-bleeding
Official Title
Emergency Capsule Endoscopy in Severe GI-bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary objective: Evaluation of capsule endoscopy in the emergency setting of severe GI-Bleeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GI-bleeding
Keywords
GI-bleeding, capsule endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
capsule endoscopy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
capsule endoscopy
Primary Outcome Measure Information:
Title
the influence of capsule endoscopy on guidance of further diagnostic or therapeutic procedures.
Time Frame
after complete recruitment
Secondary Outcome Measure Information:
Title
frequency of mid-GI-bleeding in all patients
Title
diagnostic yield
Time Frame
after complete recruitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Klinikum rechts der Isar
City
München
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25432532
Citation
Schlag C, Menzel C, Nennstiel S, Neu B, Phillip V, Schuster T, Schmid RM, von Delius S. Emergency video capsule endoscopy in patients with acute severe GI bleeding and negative upper endoscopy results. Gastrointest Endosc. 2015 Apr;81(4):889-95. doi: 10.1016/j.gie.2014.09.035.
Results Reference
derived
Learn more about this trial
Emergency Capsule Endoscopy in Severe GI-bleeding
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