Clinical Trial: Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary: 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.
Sponsor: Odense University Hospital

Current Primary Outcome: Rebleeding [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Odense University Hospital

Dates:
Date Received: November 12, 2014
Date Started: January 2014
Date Completion: March 2018
Last Updated: April 19, 2017
Last Verified: April 2017