Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Recruiting
    • Department of Gastrointestinal Surgery, Aalborg University Hospital
    • Contact: Per Ejstrud, MD; Phone Number: +45 20645297; Email: pee@rn.dk
  • Odense, Denmark
    • Recruiting
    • Department of gastroenterology, Odense University Hospital
    • Contact: Stig Laursen, MDPhD; Phone Number: +45 30207859; Email: Stig.laursen@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Severe comorbidity with a remaining life expectancy below 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	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
Active Comparator: Supplementary doppler-guided endoscopic therapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding-related mortality	Number of participants who die within 30 days from primary endoscopy because of severe rebleeding.	1 month
Complications to endoscopic therapy	Number of participants who develop complications to applied endoscopic therapy.	1 month

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: S-20130140