Clinical Trial: Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial

Brief Summary: Peptic ulcer bleeding is a common disorder. Despite optimal endoscopic and medical treatment, there is a high risk of rebleeding and high mortality. In this study the investigators examine whether combined endoscopic haemostasis and angiographic embolization resolves in a better outcome than the traditional use of endoscopic haemostasis alone. The study is a randomised controlled trail.

Detailed Summary:
Sponsor: Odense University Hospital

Current Primary Outcome: Composite Endpoint [ Time Frame: Meassured after a week from primary therapeutic endoscopy ]

Patients are classified into groups depending on the worst outcome:

  1. No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
  2. No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
  3. Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization.
  4. Rebleeding requiring surgery.
  5. Patients who have died.

Results are compared using the Wilcoxon rank sum test.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: 1 month ]
    Patients who have died within af month from therapeutic endoscopy.
  • Rebleeding [ Time Frame: 1 month ]
    Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
  • Blood transfusion [ Time Frame: 1 month ]
    Amount of received blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L. Patients will only receive blood transfusion if hemoglobin < 6,0mmol/L
  • Surgical haemostasis [ Time Frame: 1 month ]
    Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
  • Endoscopic/other haemostatic retreatment [ Time Frame: 1 month ]
    Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
  • Duration of hospitalization [ Time Frame: Estimated 4 days ]
    Time from hospitalization to discharge.
  • Thromboembolic complications [ Time Frame: 1 month ]
    Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.


Original Secondary Outcome:

  • Mortality [ Time Frame: 1 month ]
    Patients who have died within af month from therapeutic endoscopy.
  • Rebleeding [ Time Frame: 1 month ]
    Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
  • Blood transfusion [ Time Frame: 1 month ]
    Amount of recieved blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L. Patients will only recieve blood transfusion if hemoglobin < 6,0mmol/L
  • Surgical haemostasis [ Time Frame: 1 month ]
    Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
  • Endoscopic/other haemostatic retreatment [ Time Frame: 1 month ]
    Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
  • Duration of hospitalization [ Time Frame: Estimated 4 days ]
    Time from hospitalization to discharge.
  • Thromboembolic complications [ Time Frame: 1 month ]
    Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.


Information By: Odense University Hospital

Dates:
Date Received: May 10, 2010
Date Started: September 2009
Date Completion:
Last Updated: May 13, 2013
Last Verified: May 2013