Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

Odense University Hospital

Status: Unknown

Conditions: Peptic Ulcer Bleeding

Treatments: Drug: IV. PPI; Other: Endoscopic treatment at primary endoscopy; Device: Supplementary endoscopy with doppler-guided therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02434978

S-20130140

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Severe comorbidity with a remaining life expectancy below 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 2 patient groups, including a placebo group

Supplementary doppler-guided endoscopic therapy

Active Comparator group

Treatment:

Other: Endoscopic treatment at primary endoscopy

Drug: IV. PPI

Device: Supplementary endoscopy with doppler-guided therapy

control group

Placebo Comparator group

Treatment:

Other: Endoscopic treatment at primary endoscopy

Drug: IV. PPI