Clinical Trial: Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy
Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy
Brief Summary: Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
Detailed Summary:
Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Current Primary Outcome: Persistent bleeding or Rebleeding with 7 days [ Time Frame: 7 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- blood units transfused [ Time Frame: 30 days ]
- duration of hospital stay [ Time Frame: 30 days ]
- duration of intensive care unit stay [ Time Frame: 30 days ]
- 30 d Mortality [ Time Frame: 30 days ]
- Amount of endoscopic reinterventions [ Time Frame: 7 d ]
- Necessity of surgical or angiographic therapy [ Time Frame: 7 d ]
- Complications during or after OTSC (Over The Scope Clip) placement [ Time Frame: 7 d ]
Original Secondary Outcome: Same as current
Information By: Kliniken Ludwigsburg-Bietigheim gGmbH
Dates:
Date Received: April 15, 2013
Date Started: March 2013
Date Completion: April 2015
Last Updated: April 17, 2013
Last Verified: April 2013
