Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Not Applicable

Completed

• Conditions: Peptic Ulcer Hemorrhage
• Interventions: Procedure: Angiographic embolization; Procedure: Therapeutic endoscopy

• 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

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Exclusion Criteria

• Expected lifetime < 1 month
• Upper GI-cancer found at endoscopy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Angiographic embolization	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.
Control group	Therapeutic endoscopy	Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.

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