Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

NCT ID: NCT01125852

Last Updated: 2013-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Peptic Ulcer Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Angiographic embolization

Intervention Type PROCEDURE

Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.

Control group

Patients in this arm receive standard treatment including therapeutic endoscopy with endoscopic combination therapy followed by 72 hours intravenous proton pump inhibitor.

Group Type ACTIVE_COMPARATOR

Therapeutic endoscopy

Intervention Type PROCEDURE

Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.

Interventions

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Angiographic embolization

Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.

Intervention Type PROCEDURE

Therapeutic endoscopy

Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.

Intervention Type PROCEDURE

Other Intervention Names

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Therapeutic angiography Arterial embolization Transcatheter arterial embolization Embolization

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stig Borbjerg Laursen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Laursen SB, Hansen JM, Andersen PE, Schaffalitzky de Muckadell OB. Supplementary arteriel embolization an option in high-risk ulcer bleeding--a randomized study. Scand J Gastroenterol. 2014 Jan;49(1):75-83. doi: 10.3109/00365521.2013.854829. Epub 2013 Nov 21.

Reference Type DERIVED
PMID: 24256098 (View on PubMed)

Other Identifiers

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S-20090086

Identifier Type: -

Identifier Source: org_study_id

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