Back to resultsSupplementary Angiographic Embolization for Peptic Ulcer Bleeding
Primary Purpose
Peptic Ulcer Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Angiographic embolization
Therapeutic endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer Hemorrhage focused on measuring Peptic ulcer hemorrhage, Peptic ulcer bleeding, Angiographic embolization, Arterial embolization, Angiography
Eligibility 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
Sites / Locations
- Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
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.
Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.
Outcomes
Primary Outcome Measures
Composite Endpoint
Patients are classified into groups depending on the worst outcome:
No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization.
Rebleeding requiring surgery.
Patients who have died.
Results are compared using the Wilcoxon rank sum test.
Secondary Outcome Measures
Mortality
Patients who have died within af month from therapeutic endoscopy.
Rebleeding
Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
Blood transfusion
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
Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
Endoscopic/other haemostatic retreatment
Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
Duration of hospitalization
Time from hospitalization to discharge.
Thromboembolic complications
Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01125852
Brief Title
Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
Official Title
Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Hemorrhage
Keywords
Peptic ulcer hemorrhage, Peptic ulcer bleeding, Angiographic embolization, Arterial embolization, Angiography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.
Intervention Type
Procedure
Intervention Name(s)
Angiographic embolization
Other Intervention Name(s)
Therapeutic angiography, Arterial embolization, Transcatheter arterial embolization, Embolization
Intervention Description
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic endoscopy
Intervention Description
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
Primary Outcome Measure Information:
Title
Composite Endpoint
Description
Patients are classified into groups depending on the worst outcome:
No clinical signs of rebleeding and requirement of two or less blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
No clinical signs of rebleeding and requirement of more than two blood transfusions after circulatory stabilization and obtained hemoglobin > 5,9mmol/L.
Rebleeding and achieved secondary haemostasis by endoscopy or angiographic embolization.
Rebleeding requiring surgery.
Patients who have died.
Results are compared using the Wilcoxon rank sum test.
Time Frame
Meassured after a week from primary therapeutic endoscopy
Secondary Outcome Measure Information:
Title
Mortality
Description
Patients who have died within af month from therapeutic endoscopy.
Time Frame
1 month
Title
Rebleeding
Description
Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
Time Frame
1 month
Title
Blood transfusion
Description
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
Time Frame
1 month
Title
Surgical haemostasis
Description
Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
Time Frame
1 month
Title
Endoscopic/other haemostatic retreatment
Description
Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
Time Frame
1 month
Title
Duration of hospitalization
Description
Time from hospitalization to discharge.
Time Frame
Estimated 4 days
Title
Thromboembolic complications
Description
Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
24256098
Citation
Laursen SB, Hansen JM, Andersen PE, Schaffalitzky de Muckadell OB. Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study. Scand J Gastroenterol. 2014 Jan;49(1):75-83. doi: 10.3109/00365521.2013.854829. Epub 2013 Nov 21.
Results Reference
derived
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Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
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