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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 10, 2010
Last Updated Date	May 13, 2013
Start Date ^ICMJE	September 2009
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 18, 2010)	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: 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01125852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 11, 2012)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: May 18, 2010)	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 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 ] [ 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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Peptic Ulcer Hemorrhage
Intervention ^ICMJE	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 Procedure: Therapeutic endoscopy Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
Study Arm (s)	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. Intervention: Procedure: Angiographic 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. Intervention: Procedure: Therapeutic endoscopy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	105
Completion Date	May 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Denmark

Administrative Information
NCT Number ^ICMJE	NCT01125852
Other Study ID Numbers ^ICMJE	S-20090086
Has Data Monitoring Committee	No
Responsible Party	Stig Borbjerg Laursen, Odense University Hospital
Study Sponsor ^ICMJE	Odense University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Odense University Hospital
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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