Clinical trial NCT00766961: TAE and Surgery in Patients With Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Official title: Randomized Comparison of Trans-catheter Arterial Embolization (TAE) and Surgery in Patients With Major Peptic Ulcer Bleeding Uncontrolled by Endoscopic Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peptic Ulcer
Bleeding
Keywords: Peptic ulcer bleeding uncontrolled by endoscopic therapy.
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Erasme University Hospital
name: King Chulalongkorn Memorial Hospital
First posted: 2008-10-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality within 30 days of randomization
timeFrame: 30 days
Secondary outcomes:
measure: Recurrent bleeding after assigned treatment
timeFrame: 60 days
measure: The need for additional intervention either in the form of interventional radiology
timeFrame: 60 days
measure: Post procedural morbidities
timeFrame: 60 days
measure: The need for additional intervention either in the form of surgery
timeFrame: 60 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: James YW LAU, MD
role: PRINCIPAL_INVESTIGATOR
References: