Over-the-scope Clips and Standard Treatments in Endoscopic Control of Acute Bleeding From Non-variceal Upper GI Causes
Status:
Completed
Trial end date:
2021-01-16
Target enrollment:
Participant gender:
Summary
In the management of patients with acute upper gastrointestinal bleeding from non-variceal
causes, endoscopic treatment and acid suppression are now the standard of care. Current
endoscopic treatment in the form of either thermo-coagulation or clipping to the bleeding
arteries is highly efficacious in the stopping bleeding. Unfortunately in 5 to 10% of
patients, bleeding cannot be controlled during index endoscopy or recurs after initial
hemostasis. These patients are often elderly with significant co-morbidities. Their bleeding
lesions are large eroding into major sub-serosal arteries. In the few who need surgical
salvage, mortality increases to around 30%. The Over-the-scope-Clip (OTSC) is a device, which
allows endoscopists to capture a large amount of tissue and compress on the bleeding artery.
The OTSC also has a high retention rate. Recurrent bleeding with the use of standard
hemo-clips can occur because of their low retention rate. We reported the use of OTSC with a
high success rate in a case series of patients with refractory bleeding after standard
endoscopic treatment. We have also used OTSC in the treatment of bleeding from
pseudo-aneurysm arising from large eroded arteries in ulcer base. A multicenter randomized
controlled trial that compares OTSC to standard endoscopic treatment in the endoscopic
treatment of refractory bleeding lesions has just been completed. The use of OTSC has been
shown to be superior in achieving hemostatic control and reducing further bleeding. In this
proposed randomized controlled trial, we would test the hypothesis that the use of OTSC, when
used as the first or primary treatment, is superior to standard treatment in achieving
hemostasis and thereby improve patients' outcomes.
Phase:
N/A
Details
Lead Sponsor:
Chinese University of Hong Kong
Collaborators:
Beijing Friendship Hospital Ningbo No. 1 Hospital Queen Mary Hospital, Hong Kong The First Affiliated Hospital of Soochow University Zhejiang University