Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

NCT ID: NCT02434978

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-03-31

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supplementary doppler-guided endoscopic therapy

Group Type ACTIVE_COMPARATOR

Supplementary endoscopy with doppler-guided therapy

Intervention Type DEVICE

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.

IV. PPI

Intervention Type DRUG

All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.

Endoscopic treatment at primary endoscopy

Intervention Type OTHER

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

control group

Group Type PLACEBO_COMPARATOR

IV. PPI

Intervention Type DRUG

All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.

Endoscopic treatment at primary endoscopy

Intervention Type OTHER

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

Interventions

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Supplementary 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.

Intervention Type DEVICE

IV. PPI

All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.

Intervention Type DRUG

Endoscopic 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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stig Borbjerg Laursen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of gastrointestinal surgery, Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Department of gastroenterology, Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Stig Laursen, MD PhD

Role: CONTACT

+45 30207859

Facility Contacts

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Per Ejstrud, MD

Role: primary

+45 20645297

Stig Laursen, MDPhD

Role: primary

+45 30207859

Other Identifiers

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S-20130140

Identifier Type: -

Identifier Source: org_study_id

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