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

NCT ID: NCT04902248

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-27
• Study Completion Date: 2025-12-24

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.

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

The OTSC® System Set

Intervention Type: DEVICE

The endoscope was extracted and equipped with the OTSC system. OTSC system is deployed on the lesion with suction to target lesion

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.

Group Type: EXPERIMENTAL

angiographic embolization

Intervention Type: PROCEDURE

Transcatheter selective embolization to bleeding arteries

Interventions

The 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

Intervention Type: DEVICE

angiographic embolization

Transcatheter selective embolization to bleeding arteries

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

James Yun-wong Lau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yau Wong James Lau, MD

Role: PRINCIPAL_INVESTIGATOR

The Chinese University of HongKong

Locations

Beijing friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Huaxi Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, N.T., Hong Kong

Site Status: RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status: RECRUITING

Countries

China; Hong Kong; Thailand

Central Contacts

Yau Wong James Lau, MD

Role: CONTACT

laujyw@surgery.cuhk.edu.hk

35052640

Yuanyuan yu, phd

Role: CONTACT

karinayu@surgery.cuhk.edu.hk

35052640

Facility Contacts

PENG LI, MD

Role: primary

lipeng@ccmu.edu.cn

6301 4411 ext. 3482

SIUJING SUN, MD

Role: backup

6301 4411 ext. 3482

LI HU, MD

Role: primary

liaoy101@126.com

+86-791-88692748

MD

Role: backup

liaoy101@126.com

+86-791-88692748

XIAO-CUN XING, MD

Role: primary

XUE XIAO, MD

Role: backup

James YW LAU, MD

Role: primary

laujyw@surgery.cuhk.edu.hk

+852350522640

Bing-yee SUEN, MHSc

Role: backup

suenbingyee@surgery.cuhk.edu.hk

+85235052640

Parit Mekaroonkamol, MD

Role: primary

Supakarn Chaithongrat, MD

Role: backup

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

OTSCTAE

Identifier Type: -

Identifier Source: org_study_id