Overview

This trial is active, not recruiting.

Conditions bleeding, peptic ulcer, arterial embolization
Treatments tae, no tae
Phase phase 4
Sponsor Chinese University of Hong Kong
Collaborator King Chulalongkorn Memorial Hospital
Start date January 2010
End date July 2014
Trial size 250 participants
Trial identifier NCT01142180, TAE2

Summary

The aim of this study is to determine if early angiographic embolization can forestall recurrent bleeding in selected high risk ulcers after their initial endoscopic control; to validate prospectively the investigators proposed in selecting high risk ulcers for recurrent bleeding in spite of maximal endoscopic control and profound acid suppression using high dose intravenous infusion of proton pump inhibitor; to characterize the nature of bleeding arteries in severely bleeding peptic ulcers and determine the efficacy of angiographic embolization in the prevention of recurrent bleeding and to establish safety profile of angiographic embolization as an early elective treatment to bleeding peptic ulcers.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients will be undergone TAE after endoscopic hemostasis.
tae Transarterial embolization
The procedure will be performed within 12 hours of endoscopic therapy. This is usually performed under conscious sedation
(Active Comparator)
No TAE procedure will be performed after endoscopic treatment.
no tae
No TAE procedure will be performed after endoscopic treatment

Primary Outcomes

Measure
clinical re-bleeding
time frame: within 30 days of therapy

Secondary Outcomes

Measure
death from all causes
time frame: within 30 days of therapy
transfusion requirement
time frame: within 30 days of therapy
hospital stay including Intensive Care Unit stay
time frame: within 30 days of therapy
further interventions either further TAE or surgery
time frame: within 30 days of therapy
hospital costs
time frame: within 30 days of therapy

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Actively bleeding peptic ulcers (Forrest I), NBVV or Forrest IIa ulcer, - Successful endoscopic hemostasis by combination treatment of injected epinephrine followed by either 3.2mm heat probe 30J (4 continuous pulses) or hemo-clipping (at least 2 clips) And one of the followings - Spurting hemorrhage during endoscopy; - Ulcer >= 2 cm is determined by an opened biopsy forceps; - Hb on admission of < 9 g/dl; or - Hypotension prior to endoscopy defined by SBP of <90 mmHg AND HR of >110 bmp Exclusion Criteria:

Additional Information

Official title Early Selective Angiographic Embolization to Severely Bleeding Peptic Ulcers After Their Initial Endoscopic Hemostasis - a Randomized Controlled Trial
Principal investigator James Y LAU, MD
Description Endoscopic therapy is now the treatment of choice in patients with actively bleeding peptic ulcers and ulcers with non-bleeding visible vessels. Following endoscopic control of bleeding, we showed that the use of a high dose intravenous infusion of proton pump inhibitor (PPI) for 72 hours further reduced rate of recurrent bleeding [Lau NEJM 2000]. Recurrent bleeding still occurs in 8 to 10 percent of patients who receive the above treatment regime. The associated mortality following a rebleed is 4-10 fold higher when compared to those without recurrent bleeding. In a logistic regression model involving 1144 patients after successful endoscopic thermocoagulation to their bleeding peptic ulcers, we demonstrated that several factors independently predicted recurrent bleeding. They included hypotension, hemoglobin <10g/dl, fresh blood in the stomach, ulcer size > 2cm and active bleeding during endoscopy [Wong Gut 2003]. When we applied this model in a cohort of 945 patients who underwent endoscopic control of bleeding to their ulcers and adjunctive use of high dose intravenous PPI, 275 belonged to the high risk group. Of them, rebleeding leading to surgery or death occurred in 46 patients (16.7%)[Chiu DDW 2007]. Endoscopic treatment to bleeding peptic ulcers has its own limit. In an ex vivo bleeding model using canine mesenteric arteries, endoscopic thermocoagulation could only consistently seal arteries up to 2 mm in size [Johnson Gastro 1987]. Trans-arterial angiography allows clinicians to study and characterize bleeding arteries underneath peptic ulcers. In ulcers that erode into major arteries such as the gastro-duodenal artery complex and branches from left gastric artery, angiography complements endoscopic therapy in the form of selective coiling of the bleeding artery. Trans-arterial angiographic coiling can provide definitive control of bleeding from larger arteries i.e. > 2 mm in size. In cohort studies, trans-arterial angiographic coiling has been shown to compare favorably to surgery, and is less invasive in the control of severe bleeding in peptic
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.