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

Not Applicable

Recruiting

• Conditions: Upper Gastrointestinal Bleeding

• Registration Number: NCT04902248
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-26
• Study Start: 2021-11-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-05-25
• Study Completion: 2025-12-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
further interventions	within 30 days after randomization	repeat endoscopic therapy, interventional radiology or surgery performed for management of further bleeds or a complication of a study intervention
blood transfusion	within 30 days after randomization	total units of blood transfusion
length of ICU stay	within 30 days after randomization	duration of ICU stay
mortality related to bleeding	within 30 days after randomization	the number of bleeding caused death
length of hospitalization	within 30 days after randomization	duration of hospitalization
all cause mortality	within 30 days after randomization	the number of death

Trial Locations

Locations (5)

Beijing friendship Hospital; 🇨🇳 Beijing, Beijing, 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, Thailand