Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding
Primary Purpose
Peptic Ulcer Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Supplementary endoscopy with doppler-guided therapy
IV. PPI
Endoscopic treatment at primary endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer Bleeding
Eligibility Criteria
Inclusion Criteria:
- Peptic ulcer bleeding from ulcers classified as Forrest I-IIb
Exclusion Criteria:
- Severe comorbidity with a remaining life expectancy below 30 days
Sites / Locations
- Department of gastrointestinal surgery, Aalborg University HospitalRecruiting
- Department of gastroenterology, Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Supplementary doppler-guided endoscopic therapy
control group
Arm Description
Outcomes
Primary Outcome Measures
Rebleeding
Number of participants who develop symptoms of rebleeding combined with a significant drop in systolic blood pressure, or B-haemoglobin, or confirmation of stigmata of bleeding at repeat endoscopy/angiography/surgery.
Secondary Outcome Measures
Bleeding-related mortality
Number of participants who die within 30 days from primary endoscopy because of severe rebleeding.
Complications to endoscopic therapy
Number of participants who develop complications to applied endoscopic therapy.
Full Information
NCT ID
NCT02434978
First Posted
November 12, 2014
Last Updated
April 19, 2017
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02434978
Brief Title
Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study is a randomized controlled trial (RCT) that examines if the outcome of peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.
Detailed Description
This study evaluates if performance of a control endoscopy with doppler-guided endoscopic treatment is associated with an improved outcome in term of lower rate of rebleeding and lower rate of bleeding-related mortality. A potential risk of increased risk of complications (in particular perforation) among patients treated with control endoscopy is also evaluated. Outcomes are prospectively registered based on patient records.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Supplementary doppler-guided endoscopic therapy
Arm Type
Active Comparator
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Supplementary endoscopy with doppler-guided therapy
Intervention Description
Patients randomized to supplementary doppler-guided therapy undergo repeat endoscopy with doppler evaluation within 24 hours from the primary endoscopy. At the control endoscopy the ulcer base is examined using a doppler device. If active doppler flow is demonstrated the ulcer is treated with a thermal probe until a control doppler-scan is negative. All patients are observed for rebleeding at a specialized GI-bleeding unit.
Intervention Type
Drug
Intervention Name(s)
IV. PPI
Intervention Description
All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.
Intervention Type
Other
Intervention Name(s)
Endoscopic treatment at primary endoscopy
Intervention Description
All patients are initially treated with endoscopic therapy using a minimum of two different treatment modalities. The primary endoscopy is performed wihtin 24 hours from time of admission to hospital
Primary Outcome Measure Information:
Title
Rebleeding
Description
Number of participants who develop symptoms of rebleeding combined with a significant drop in systolic blood pressure, or B-haemoglobin, or confirmation of stigmata of bleeding at repeat endoscopy/angiography/surgery.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Bleeding-related mortality
Description
Number of participants who die within 30 days from primary endoscopy because of severe rebleeding.
Time Frame
1 month
Title
Complications to endoscopic therapy
Description
Number of participants who develop complications to applied endoscopic therapy.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Peptic ulcer bleeding from ulcers classified as Forrest I-IIb
Exclusion Criteria:
Severe comorbidity with a remaining life expectancy below 30 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stig Laursen, MD PhD
Phone
+45 30207859
Email
stig.laursen@rsyd.dk
Facility Information:
Facility Name
Department of gastrointestinal surgery, Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Per Ejstrud, MD
Phone
+45 20645297
Email
pee@rn.dk
Facility Name
Department of gastroenterology, Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stig Laursen, MDPhD
Phone
+45 30207859
Email
Stig.laursen@rsyd.dk
12. IPD Sharing Statement
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Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding
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