Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Not Applicable

Completed

• Conditions: Peptic Ulcer Hemorrhage

• Registration Number: NCT01125852
• Lead Sponsor: Odense University Hospital

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 available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite Endpoint	Meassured after a week from primary therapeutic endoscopy	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

Name	Time	Method
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.

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark