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

Condition(s) studied

Investigational drug(s) / intervention(s)

The OTSC® System Set: The endoscope was extracted and equipped with the OTSC system. OTSC system is deployed on the lesion with suction to target lesion

angiographic embolization: Transcatheter selective embolization to bleeding arteries

Study summary

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

Primary outcome measure(s)

• further bleeding — within 30 days after randomization
  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).

Trial sites (5)

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