Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

Not Applicable

• Conditions: Peptic Ulcer Bleeding
• Interventions: Device: Supplementary endoscopy with doppler-guided therapy; Drug: IV. PPI; Other: Endoscopic treatment at primary endoscopy

• Registration Number: NCT02434978
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20
• Primary Completion: 2017-09
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

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

Read More

Exclusion Criteria

• Severe comorbidity with a remaining life expectancy below 30 days

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supplementary doppler-guided endoscopic therapy	Supplementary endoscopy with doppler-guided therapy	-
control group	IV. PPI	-
control group	Endoscopic treatment at primary endoscopy	-
Supplementary doppler-guided endoscopic therapy	IV. PPI	-
Supplementary doppler-guided endoscopic therapy	Endoscopic treatment at primary endoscopy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Department of gastrointestinal surgery, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of gastroenterology, Odense University Hospital; 🇩🇰 Odense, Denmark