Supplementary Angiographic Embolization for Peptic Ulcer Bleeding

Odense University Hospital

Status: Completed

Conditions: Peptic Ulcer Hemorrhage

Treatments: Procedure: Angiographic embolization; Procedure: Therapeutic endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01125852

S-20090086

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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.

Treatment:

Procedure: Angiographic embolization

Control group

Active Comparator group

Description:

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

Treatment:

Procedure: Therapeutic endoscopy