NCT01125852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

2.7 years

First QC Date

May 10, 2010

Last Update Submit

May 13, 2013

Conditions

Peptic Ulcer Hemorrhage

Keywords

Peptic ulcer hemorrhagePeptic ulcer bleedingAngiographic embolizationArterial embolizationAngiography

Outcome Measures

Primary Outcomes (1)

  • Composite Endpoint

    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.

    Meassured after a week from primary therapeutic endoscopy

Secondary Outcomes (7)

  • Mortality

    1 month

  • Rebleeding

    1 month

  • Blood transfusion

    1 month

  • Surgical haemostasis

    1 month

  • Endoscopic/other haemostatic retreatment

    1 month

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Interventions

Angiographic embolizationPROCEDURE

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

Also known as: Therapeutic angiography, Arterial embolization, Transcatheter arterial embolization, Embolization
Intervention group
Therapeutic endoscopyPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical signs of upper GI-bleeding
  • Endoscopic verified high-risk ulcer (Forrest I-IIb)
  • Primary haemostasis achieved

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24256098DERIVED

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Gastrointestinal HemorrhageGastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 19, 2010

Study Start

September 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

DK(1)