Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

Study Overview
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Brief Summary
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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
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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.

Conditions
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Peptic Ulcer Bleeding

Intervention / Treatment
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* Device: Supplementary endoscopy with doppler-guided therapy
* Drug: IV. PPI
* Other: Endoscopic treatment at primary endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peptic ulcer bleeding from ulcers classified as Forrest I-IIb Exclusion Criteria: Severe comorbidity with a remaining life expectancy below 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supplementary doppler-guided endoscopic therapy<br> | Device: Supplementary endoscopy with doppler-guided therapy<br>* 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.<br>Drug: IV. PPI<br>* All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.<br>Other: Endoscopic treatment at primary endoscopy<br>* 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<br>|
| Placebo Comparator: control group<br> | Drug: IV. PPI<br>* All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.<br>Other: Endoscopic treatment at primary endoscopy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding-related mortality | Number of participants who die within 30 days from primary endoscopy because of severe rebleeding. | 1 month | 
| Complications to endoscopic therapy | Number of participants who develop complications to applied endoscopic therapy. | 1 month |