OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Upper Gastrointestinal Bleeding
About this trial
This is an interventional treatment trial for Upper Gastrointestinal Bleeding focused on measuring Over-the-scope clips, angiographic embolization
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Beijing friendship Hospital
- Huaxi Hospital of Sichuan UniversityRecruiting
- Endoscopy Centre, Prince of Wales HospitalRecruiting
- King Chulalongkorn Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Over-the-scope clips
angiographic embolization
The OTSC® System Set is an instrument for flexible endoscopy The OTSC® System Set consists of an applicator cap with a mounted OTSC® clip, thread, thread retriever and a hand wheel for clip release. The OTSC® clip is delivered by means of an applicator cap mounted to the tip of gastroscopes or colonoscopes. The clip is released by tightening the thread with the hand wheel. The OTSC® clip for flexible endoscopy is a superelastic Nitinol device for compression and approximation of tissue in the digestive tract
The procedure was performed in the angiographic suite and under local anaesthetics to the patient's groin. The celiac and then gastroduodenal artery or the left gastric artery was selectively cannulated depending on ulcer location. Coils were deposited distal to the bleeding point. Gel foam particles were then packed into the artery and its collaterals. This was followed by further coils deposited in its proximal portion until complete cessation of arterial flow. Our protocol requested empiric embolisation of the artery even in the absence of active contrast extravasation or a pseudoaneurysm.