Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Sponsor

Odense University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01125852

Collaborator

(none)

105

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer Hemorrhage	Procedure: Angiographic embolization Procedure: Therapeutic endoscopy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Composite Endpoint [Meassured after a week from primary therapeutic endoscopy]
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 [1 month]
Patients who have died within af month from therapeutic endoscopy.
Rebleeding [1 month]
Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
Blood transfusion [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 [1 month]
Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
Endoscopic/other haemostatic retreatment [1 month]
Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
Duration of hospitalization [Estimated 4 days]
Time from hospitalization to discharge.
Thromboembolic complications [1 month]
Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.