Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Peptic Ulcer Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125852
• Other study ID #: S-20090086
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: May 13, 2013
• Start date: September 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Procedure:
• Angiographic embolization
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
• Therapeutic endoscopy
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Mortality	Patients who have died within af month from therapeutic endoscopy.	1 month	Yes
Secondary	Rebleeding	Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.	1 month	Yes
Secondary	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	No
Secondary	Surgical haemostasis	Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.	1 month	Yes
Secondary	Endoscopic/other haemostatic retreatment	Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.	1 month	Yes
Secondary	Duration of hospitalization	Time from hospitalization to discharge.	Estimated 4 days	Yes
Secondary	Thromboembolic complications	Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.	1 month	Yes