Peptic Ulcer Bleeding
Conditions
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.
Interventions
DEVICESupplementary endoscopy with doppler-guided therapy
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.
DRUGIV. PPI
All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.
OTHEREndoscopic treatment at primary endoscopy
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
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Peptic ulcer bleeding from ulcers classified as Forrest I-IIb
Exclusion criteria
* Severe comorbidity with a remaining life expectancy below 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding | 1 week | 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
| Measure | Time frame | Description |
|---|---|---|
| Bleeding-related mortality | 1 month | Number of participants who die within 30 days from primary endoscopy because of severe rebleeding. |
| Complications to endoscopic therapy | 1 month | Number of participants who develop complications to applied endoscopic therapy. |
Countries
Denmark
Contacts
Primary ContactStig Laursen, MD PhD
Outcome results
None listed