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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing friendship Hospital
RECRUITING
Beijing
Huaxi Hospital of Sichuan University
RECRUITING
Chengdu
the First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Hong Kong Special Administrative Region
Endoscopy Centre, Prince of Wales Hospital
RECRUITING
Hong Kong
Thailand
King Chulalongkorn Memorial Hospital
RECRUITING
Bangkok
Contact Information
Primary
Yau Wong James Lau, MD
laujyw@surgery.cuhk.edu.hk
35052640
Backup
Yuanyuan yu, phd
karinayu@surgery.cuhk.edu.hk
35052640
Time Frame
Start Date: 2021-11-27
Estimated Completion Date: 2025-12-24
Participants
Target number of participants: 236
Treatments
Experimental: Over-the-scope clips
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
Experimental: angiographic embolization
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.
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov