Clinical trial NCT04902248: OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
Official title: Endoscopic Application of Over-the-scope Clips (OTSC) vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding: a Multicenter Randomized Comparison
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Keywords: Over-the-scope clips
angiographic embolization
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The current standard of care in patients with refractory bleeding from their peptic ulcers and other non-variceal causes has not been defined. An International Consensus Group recommends a surgical consult when endoscopic treatment has failed and TAE should be considered as an alternative. The European guidelines recommend the use of either surgery or angiographic embolization. There has not been a fully published RCT that compares angiographic treatment to surgery in those with refractory bleeding. Several comparative series mostly retrospective and their meta-analyses suggest that outcomes following TAE would not be dissimilar to those after surgery. Common to these reports, TAE is associated with a higher rate of further bleeds. In our meta-analysis , the pooled rate of further bleeds after TAE was 51/178(32%) compared to that of 26/241 (14.9%) after surgery. A high rate of further bleeding can be understood because of a rich vascular supply to peptic ulcers especially those in the bulbar duodenum. A bulbar ulcer receives dual arterial supply from celiac and superior mesenteric arteries. Embolization to these arteries can therefore be challenging. In a population-based study from northern Europe that included 282 patients (97 TAE and 185 surgery), the overall hazard of deaths after TAE decreased by 1/3 when compared to surgery. Many argue that TAE is preferred over surgery in the algorithm of management.

The use of OTSC has emerged as an alternative before TAE which is often considered most definitive. A multicenter randomized controlled trial that compared OTSC and standard endoscopic treatment mostly through-the-scope clips in patients with refractory bleeding peptic ulcers; 66 patients were randomized and control of bleeding over 30 days was better with the use of OTSC (15.2% vs. 57.6%). A Mayo Clinic group reported OTSC treatment in 67 high risk lesions defined by those near an arterial complex (bulbar or angular/lesser curve ulceration) with an artery larger than 2 mm, deep excavated fibrotic ulcer with major stigmata and those that failed standard endoscopic therapy (through-the-scope clips and/or thermal device); 47 (70.1%) remained free of further bleeds at day 30 10.

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:

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

Primary outcomes:
measure: further bleeding
timeFrame: within 30 days after randomization
Secondary outcomes:
measure: further interventions
timeFrame: within 30 days after randomization
measure: blood transfusion
timeFrame: within 30 days after randomization
measure: length of hospitalization
timeFrame: within 30 days after randomization
measure: length of ICU stay
timeFrame: within 30 days after randomization
measure: mortality related to bleeding
timeFrame: within 30 days after randomization
measure: all cause mortality
timeFrame: within 30 days after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing friendship Hospital
state: Beijing
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Chengdu
country: China
facility: Huaxi Hospital of Sichuan University
state: Sichuan
city: Hong Kong
country: Hong Kong
facility: Endoscopy Centre, Prince of Wales Hospital
state: N.t.
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: The Chinese University of HongKong
name: Yau Wong James Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
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