Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

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

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.

Study Overview

• Status: Completed
• Conditions: Peptic Ulcer Hemorrhage
• Intervention / Treatment: Procedure: Angiographic embolization; Procedure: Therapeutic endoscopy

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Therapeutic angiography; Arterial embolization; Transcatheter arterial embolization; Embolization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Patients who have died within af month from therapeutic endoscopy.	1 month
Rebleeding	Rebleeding from ulcer confirmed by endoscopy, angiography or surgery within a month from therapeutic endoscopy.	1 month
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
Surgical haemostasis	Rebleeding requiring surgical haemostasis within a month from therapeutic endoscopy.	1 month
Endoscopic/other haemostatic retreatment	Rebleeding confirmed by endoscopy or angiography and achieved secondary haemostasis by endoscopy or angiographic embolization.	1 month
Duration of hospitalization	Time from hospitalization to discharge.	Estimated 4 days
Thromboembolic complications	Occurence of thromboembolic complications due to angiographic embolization, surgery or therapeutic endoscopy.	1 month

Collaborators and Investigators

• Sponsor: Odense University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 10, 2010
• First Submitted That Met QC Criteria: May 18, 2010
• First Posted (Estimate): May 19, 2010

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Angiography; Peptic ulcer bleeding; Peptic ulcer hemorrhage; Angiographic embolization; Arterial embolization
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Gastrointestinal Hemorrhage; Ulcer; Hemorrhage; Peptic Ulcer; Peptic Ulcer Hemorrhage
• Other Study ID Numbers: S-20090086