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

Upper Gastrointestinal Bleeding Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902248
• Other study ID #: OTSCTAE
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2021
• Est. completion date: December 24, 2025

Study information

• Verified date: June 2024
• Source: Chinese University of Hong Kong
• Contact: Yau Wong James Lau, MD
• Phone: 35052640
• Email: laujyw[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: December 24, 2025
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Device:
• 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

Procedure:
• angiographic embolization
Transcatheter selective embolization to bleeding arteries

Locations

Country	Name	City	State
China	Beijing friendship Hospital	Beijing	Beijing
China	Huaxi Hospital of Sichuan University	Chengdu	Sichuan
China	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
Hong Kong	Endoscopy Centre, Prince of Wales Hospital	Hong Kong	N.t.
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Countries where clinical trial is conducted

China,  Hong Kong,  Thailand, 

References & Publications (7)

Barkun AN, Almadi M, Kuipers EJ, Laine L, Sung J, Tse F, Leontiadis GI, Abraham NS, Calvet X, Chan FKL, Douketis J, Enns R, Gralnek IM, Jairath V, Jensen D, Lau J, Lip GYH, Loffroy R, Maluf-Filho F, Meltzer AC, Reddy N, Saltzman JR, Marshall JK, Bardou M. — View Citation

Beggs AD, Dilworth MP, Powell SL, Atherton H, Griffiths EA. A systematic review of transarterial embolization versus emergency surgery in treatment of major nonvariceal upper gastrointestinal bleeding. Clin Exp Gastroenterol. 2014 Apr 16;7:93-104. doi: 10 — View Citation

Gralnek IM, Dumonceau JM, Kuipers EJ, Lanas A, Sanders DS, Kurien M, Rotondano G, Hucl T, Dinis-Ribeiro M, Marmo R, Racz I, Arezzo A, Hoffmann RT, Lesur G, de Franchis R, Aabakken L, Veitch A, Radaelli F, Salgueiro P, Cardoso R, Maia L, Zullo A, Cipollett — View Citation

Kyaw M, Tse Y, Ang D, Ang TL, Lau J. Embolization versus surgery for peptic ulcer bleeding after failed endoscopic hemostasis: a meta-analysis. Endosc Int Open. 2014 Mar;2(1):E6-E14. doi: 10.1055/s-0034-1365235. Epub 2014 Mar 7. — View Citation

Schmidt A, Golder S, Goetz M, Meining A, Lau J, von Delius S, Escher M, Hoffmann A, Wiest R, Messmann H, Kratt T, Walter B, Bettinger D, Caca K. Over-the-Scope Clips Are More Effective Than Standard Endoscopic Therapy for Patients With Recurrent Bleeding — View Citation

Sverden E, Mattsson F, Lindstrom D, Sonden A, Lu Y, Lagergren J. Transcatheter Arterial Embolization Compared With Surgery for Uncontrolled Peptic Ulcer Bleeding: A Population-based Cohort Study. Ann Surg. 2019 Feb;269(2):304-309. doi: 10.1097/SLA.0000000 — View Citation

Tarasconi A, Baiocchi GL, Pattonieri V, Perrone G, Abongwa HK, Molfino S, Portolani N, Sartelli M, Di Saverio S, Heyer A, Ansaloni L, Coccolini F, Catena F. Transcatheter arterial embolization versus surgery for refractory non-variceal upper gastrointesti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	further bleeding	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).	within 30 days after randomization
Secondary	further interventions	repeat endoscopic therapy, interventional radiology or surgery performed for management of further bleeds or a complication of a study intervention	within 30 days after randomization
Secondary	blood transfusion	total units of blood transfusion	within 30 days after randomization
Secondary	length of hospitalization	duration of hospitalization	within 30 days after randomization
Secondary	length of ICU stay	duration of ICU stay	within 30 days after randomization
Secondary	mortality related to bleeding	the number of bleeding caused death	within 30 days after randomization
Secondary	all cause mortality	the number of death	within 30 days after randomization