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NCT Number: NCT01125852

Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

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.

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Key information

Conditions

Peptic Ulcer Hemorrhage Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiographic embolization

Procedure

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

Other names: Therapeutic angiography, Arterial embolization, Transcatheter arterial embolization, Embolization

Therapeutic endoscopy

Procedure

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

Primary outcomes

  1. Composite Endpoint

    Time frame: Meassured after a week from primary therapeutic endoscopy

    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.

Secondary outcomes

  1. Mortality

    Time frame: 1 month

    Patients who have died within af month from therapeutic endoscopy.

  2. Rebleeding

    Time frame: 1 month

    Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.

  3. Blood transfusion

    Time frame: 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

  4. Surgical haemostasis

    Time frame: 1 month

    Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.

  5. Endoscopic/other haemostatic retreatment

    Time frame: 1 month

    Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.

  6. Duration of hospitalization

    Time frame: Estimated 4 days

    Time from hospitalization to discharge.

  7. Thromboembolic complications

    Time frame: 1 month

    Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 19, 2010
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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