OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

without a full informed consent from the patient or his next of kin

Age <18 years

Pregnant

Lactating women

Trial design

Treatments tested in this trial

  • The OTSC® System Set
  • angiographic embolization

Treatment groups

236 Participants
are divided into 2 treatment groups