RecruitingNot ApplicableNCT04902248

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

Endoscopic Application of Over-the-scope Clips (OTSC) vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding: a Multicenter Randomized Comparison


Sponsor

Chinese University of Hong Kong

Enrollment

236 participants

Start Date

Nov 27, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • \. 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

Exclusion Criteria5

  • without a full informed consent from the patient or his next of kin
  • Age \<18 years
  • Pregnant
  • Lactating women
  • patients with known allergy to intravenous contrast

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Interventions

DEVICEThe 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

PROCEDUREangiographic embolization

Transcatheter selective embolization to bleeding arteries


Locations(5)

Beijing friendship Hospital

Beijing, Beijing Municipality, China

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Huaxi Hospital of Sichuan University

Chengdu, Sichuan, China

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, N.T., Hong Kong

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

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NCT04902248


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