In the management of patients with acute upper non-variceal upper gastrointestinal bleeding, further bleeding is the most important adverse factor predictive of mortality. In the United Kingdom Audit on acute upper gastrointestinal bleeding, clinical evidence of further bleeding was reported in 13% of patients following the first endoscopy and 27% of them died. The use of OTSC has emerged as an alternative before angiographic embolization(TAE) which is often considered most definitive.
We propose to define the algorithm in the management of patients with refractory bleeding from their peptic ulcers or other non variceal causes. We hypothesize that endoscopic use of OTSC compares favourably with TAE and both lead to similar outcomes. An equivalence of the two modalities may mean that endoscopic application of OTSC should be attempted before TAE as often we need to document further bleeds with endoscopy and a second treatment should be instituted at the same time.
1. Patients presented with overt signs of acute upper gastrointestinal bleeding (hematemesis, melena and/or hypotension) 2. documented bleeding lesion at endoscopy (ulcer, dieulafoy's lesion and others), further bleeds (persistent or recurrent) after endoscopic hemostasis (thermal or hemoclips) as defined by an International Consensus Group
without a full informed consent from the patient or his next of kin
Age <18 years
Pregnant
Lactating women
Parallel
The OTSC® System Set
DeviceThe endoscope was extracted and equipped with the OTSC system. OTSC system is deployed on the lesion with suction to target lesion
angiographic embolization
Procedure/SurgeryTranscatheter selective embolization to bleeding arteries
further bleeding
Further bleeding is a composite of persistent or recurrent bleeding. Persistent bleeding is defined by active bleeding that cannot be stopped despite study intervention. For assessment of treatment efficacy, a repeat endoscopy can be performed to document further bleeding (fresh blood in the stomach and active bleeding or major stigmata of bleeding to the previously treated lesion).
further interventions
repeat endoscopic therapy, interventional radiology or surgery performed for management of further bleeds or a complication of a study intervention
blood transfusion
total units of blood transfusion
length of hospitalization
duration of hospitalization
length of ICU stay
duration of ICU stay
Click on the lead sponsor to view all of their trials.
