TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy

Bleeding Clinical Trial

Official title:

Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00766961
• Other study ID #: TAE
• Status: Terminated
• Phase: N/A
• Start date: April 2007
• Est. completion date: December 2017

Study information

• Verified date: June 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to compare the outcomes of trans-catheter arterial embolization (TAE) and surgery as salvage therapy of peptic ulcer bleeding after failed endoscopic therapy.

Description:

The aim of the study is to examine the hypothesis that trans-catheter arterial embolization (TAE) is safer than and probably as effective as surgery in the control of bleeding from ulcers after failed endoscopic therapy. Patients with major arterial bleeding that cannot be stopped by endoscopic therapy will be randomly assigned to receive immediate TAE or surgery. Primary outcome will be death within 30 days of randomization. Secondary outcomes include recurrent bleeding after assigned treatment, need for additional intervention either in the form of interventional radiology or surgery, and post procedural morbidities.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with bleeding peptic ulcers documented during endoscopic therapy AND anyone of the following:

• Forrest I bleeding that fails to be controlled by therapy during first endoscopy

• Check endoscopy after clinical re-bleeding of Forrest I bleeding

• Forrest IIa or an initial IIb but a sizable artery unveiled upon clot elevation in a high risk ulcer defined by:

• posterior bulbar duodenal ulcer > 2cm, or

• an angular notch / lesser curve gastric ulcer > 5cm that fail an attempt at endoscopic therapy together with evidence of a significant bleed (hypotension with SBP < 90mmHg, fresh hematemesis or hematochezia).

Exclusion Criteria:

• Refusal to participate in trial

• No consent

• Age < 18

• Pregnancy

• Moribund patients

• Patients with terminal malignancy

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Procedure:
• Trans-catheter arterial embolization
Trans-catheter arterial embolization
• Surgery
Surgery

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital	Hong Kong

Sponsors (4)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Erasme University Hospital, Karolinska University Hospital, King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality within 30 days of randomization	Mortality within 30 days of randomization	30 days
Secondary	Recurrent bleeding after assigned treatment	Recurrent bleeding after assigned treatment	60 days
Secondary	The need for additional intervention either in the form of interventional radiology	The need for additional intervention either in the form of interventional radiology	60 days
Secondary	Post procedural morbidities	Post procedural morbidities	60 days
Secondary	The need for additional intervention either in the form of surgery	The need for additional intervention either in the form of surgery	60 days