Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

Peptic Ulcer Bleeding Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02434978
• Other study ID #: S-20130140
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2014
• Last updated: April 19, 2017
• Start date: January 2014
• Est. completion date: March 2018

Study information

• Verified date: April 2017
• Source: Odense University Hospital
• Contact: Stig Laursen, MD PhD
• Phone: +45 30207859
• Email: stig.laursen[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Severe comorbidity with a remaining life expectancy below 30 days

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Bleeding
• Peptic Ulcer Hemorrhage

Intervention

Device:
• 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.

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

Other:
• 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

Locations

Country	Name	City	State
Denmark	Department of gastrointestinal surgery, Aalborg University Hospital	Aalborg
Denmark	Department of gastroenterology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bleeding-related mortality	Number of participants who die within 30 days from primary endoscopy because of severe rebleeding.	1 month
Secondary	Complications to endoscopic therapy	Number of participants who develop complications to applied endoscopic therapy.	1 month