Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stig Borbjerg Laursen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01125852
First received: May 10, 2010
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Peptic Ulcer Hemorrhage
Procedure: Angiographic embolization
Procedure: Therapeutic endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Composite Endpoint [ Time Frame: Meassured after a week from primary therapeutic endoscopy ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Mortality [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Patients who have died within af month from therapeutic endoscopy.

  • Rebleeding [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.

  • Blood transfusion [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.

  • Endoscopic/other haemostatic retreatment [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.

  • Duration of hospitalization [ Time Frame: Estimated 4 days ] [ Designated as safety issue: Yes ]
    Time from hospitalization to discharge.

  • Thromboembolic complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.


Enrollment: 105
Study Start Date: September 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention group
Patients in this group are treated with usual therapeutic endoscopy including endoscopic combination therapy and 72 hours intravenous proton pump inhibitor. Within 24 hours from the therapeutic endoscopy they receive supplementary angiographic embolization.
Procedure: Angiographic embolization
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
Other Names:
  • Therapeutic angiography
  • Arterial embolization
  • Transcatheter arterial embolization
  • Embolization
Active Comparator: Control group
Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.
Procedure: Therapeutic endoscopy
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical signs of upper GI-bleeding
  • Endoscopic verified high-risk ulcer (Forrest I-IIb)
  • Primary haemostasis achieved

Exclusion Criteria:

  • Expected lifetime < 1 month
  • Upper GI-cancer found at endoscopy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125852

Locations
Denmark
Odense University Hospital
Odense, Denmark
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stig Borbjerg Laursen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01125852     History of Changes
Other Study ID Numbers: S-20090086
Study First Received: May 10, 2010
Last Updated: May 13, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Peptic ulcer hemorrhage
Peptic ulcer bleeding
Angiographic embolization
Arterial embolization
Angiography

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014