Supplementary Angiographic Embolization for Peptic Ulcer Bleeding
This study has been completed.
Sponsor:
Odense University Hospital
Information provided by (Responsible Party):
Stig Borbjerg Laursen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01125852
First received: May 10, 2010
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Peptic Ulcer Hemorrhage |
Procedure: Angiographic embolization Procedure: Therapeutic endoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Supplementary Angiographic Embolization for Peptic Ulcer Bleeding: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Odense University Hospital:
Primary Outcome Measures:
- Composite Endpoint [ Time Frame: Meassured after a week from primary therapeutic endoscopy ] [ Designated as safety issue: Yes ]
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 Outcome Measures:
- Mortality [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Patients who have died within af month from therapeutic endoscopy.
- Rebleeding [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.
- Blood transfusion [ Time Frame: 1 month ] [ Designated as safety issue: No ]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 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.
- Endoscopic/other haemostatic retreatment [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.
- Duration of hospitalization [ Time Frame: Estimated 4 days ] [ Designated as safety issue: Yes ]Time from hospitalization to discharge.
- Thromboembolic complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.
| Enrollment: | 105 |
| Study Start Date: | September 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Procedure: Angiographic embolization
Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
Other Names:
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|
Active Comparator: Control group
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
Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Stig Borbjerg Laursen, MD, Odense University Hospital |
| ClinicalTrials.gov Identifier: | NCT01125852 History of Changes |
| Other Study ID Numbers: | S-20090086 |
| Study First Received: | May 10, 2010 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: The Danish National Committee on Biomedical Research Ethics |
Keywords provided by Odense University Hospital:
|
Peptic ulcer hemorrhage Peptic ulcer bleeding Angiographic embolization Arterial embolization Angiography |
Additional relevant MeSH terms:
|
Hemorrhage Peptic Ulcer Peptic Ulcer Hemorrhage Ulcer Pathologic Processes Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Stomach Diseases Gastrointestinal Hemorrhage Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013