NCT02434978

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

3.7 years

First QC Date

November 12, 2014

Last Update Submit

April 19, 2017

Conditions

Peptic Ulcer Bleeding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Bleeding-related mortality

    1 month

  • Complications to endoscopic therapy

    1 month

Study Arms (2)

Supplementary doppler-guided endoscopic therapy

ACTIVE COMPARATOR
Device: Supplementary endoscopy with doppler-guided therapyDrug: IV. PPIOther: Endoscopic treatment at primary endoscopy

control group

PLACEBO COMPARATOR
Drug: IV. PPIOther: Endoscopic treatment at primary endoscopy

Interventions

Supplementary endoscopy with doppler-guided therapyDEVICE

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.

Supplementary doppler-guided endoscopic therapy
IV. PPIDRUG

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

Supplementary doppler-guided endoscopic therapycontrol group
Endoscopic treatment at primary endoscopyOTHER

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

Supplementary doppler-guided endoscopic therapycontrol group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peptic ulcer bleeding from ulcers classified as Forrest I-IIb

You may not qualify if:

  • Severe comorbidity with a remaining life expectancy below 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of gastrointestinal surgery, Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Department of gastroenterology, Odense University Hospital

Odense, Denmark

RECRUITING

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Stig Laursen, MD PhD

CONTACT

+45 30207859stig.laursen@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 12, 2014

First Posted

May 6, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2017

Study Completion

March 1, 2018

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

DK(2)