Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Study Overview
=================
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.

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

Conditions
-----------------
Peptic Ulcer Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Angiographic embolization
* Procedure: Therapeutic endoscopy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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<br>* Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.<br>* Other names: Embolization;|
| Active Comparator: Control group<br>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<br>* Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Meassured after a week from primary therapeutic endoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Patients who have died within af month from therapeutic endoscopy. | 1 month | 
| Rebleeding | Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy. | 1 month | 
| 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 | 1 month | 
| Surgical haemostasis | Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy. | 1 month | 
| Endoscopic/other haemostatic retreatment | Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization. | 1 month | 
| Duration of hospitalization | Time from hospitalization to discharge. | Estimated 4 days | 
| Thromboembolic complications | Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peptic ulcer hemorrhage, Peptic ulcer bleeding, Angiographic embolization, Arterial embolization, Angiography