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

NCT04902248 | Recruiting DMC

• 1 other identifier: OTSCTAE
• Study Type: interventional
• Target: 236
• Locations: 3 countries
• Sites: 5

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.

Conditions

Upper Gastrointestinal Bleeding

Keywords

Over-the-scope clips; angiographic embolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• further interventions

  within 30 days after randomization

• blood transfusion

  within 30 days after randomization

• length of hospitalization

  within 30 days after randomization

• length of ICU stay

  within 30 days after randomization

• mortality related to bleeding

  within 30 days after randomization

Study Arms (2)

Over-the-scope clips

EXPERIMENTAL

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

Device: The OTSC® System Set

angiographic embolization

EXPERIMENTAL

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.

Procedure: angiographic embolization

Interventions

The OTSC® System Set DEVICE

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

Over-the-scope clips

angiographic embolization PROCEDURE

Transcatheter selective embolization to bleeding arteries

angiographic embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (5)

Beijing friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Huaxi Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, N.T., Hong Kong

RECRUITING

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, Thailand

RECRUITING

Related 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. Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group. Ann Intern Med. 2019 Dec 3;171(11):805-822. doi: 10.7326/M19-1795. Epub 2019 Oct 22.

  PMID: 31634917 RESULT

• 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, Cipolletta L, Hassan C. Diagnosis and management of nonvariceal upper gastrointestinal hemorrhage: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Oct;47(10):a1-46. doi: 10.1055/s-0034-1393172. Epub 2015 Sep 29.

  PMID: 26417980 RESULT

• 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.

  PMID: 26134614 RESULT

• 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: 10.2147/CEG.S56725. eCollection 2014.

  PMID: 24790465 RESULT

• 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 gastrointestinal bleeding: a meta-analysis. World J Emerg Surg. 2019 Feb 1;14:3. doi: 10.1186/s13017-019-0223-8. eCollection 2019.

  PMID: 30733822 RESULT

• 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.0000000000002565.

  PMID: 29064894 RESULT

• 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 of Peptic Ulcers. Gastroenterology. 2018 Sep;155(3):674-686.e6. doi: 10.1053/j.gastro.2018.05.037. Epub 2018 May 24.

  PMID: 29803838 RESULT

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yau Wong James Lau, MD

  The Chinese University of HongKong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yau Wong James Lau, MD

CONTACT

35052640; laujyw@surgery.cuhk.edu.hk

Yuanyuan yu, phd

CONTACT

35052640; karinayu@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 26, 2021
• Study Start: November 27, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); TH (1); CN (3)