Upper Gastrointestinal BleedingNCT04902248
OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding
A study testing The OTSC® System Set and angiographic embolization in people with Upper Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 5 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- The OTSC® System Set and angiographic embolization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 27 Nov 2021to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 3 countries
China3 sites, 3 recruiting
- Recruiting
Beijing friendship Hospital
Beijing, Beijing Municipality
PENG LI, MD, 6301 4411 ext. 3482, lipeng@ccmu.edu.cn
SIUJING SUN, MD, 6301 4411 ext. 3482
- Recruiting
Huaxi Hospital of Sichuan University
Chengdu, Sichuan
XIAO-CUN XING, MD
XUE XIAO, MD
- Recruiting
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
LI HU, MD, +86-791-88692748, liaoy101@126.com
+86-791-88692748, liaoy101@126.com
Hong Kong1 site, 1 recruiting
- Recruiting
Endoscopy Centre, Prince of Wales Hospital
Hong Kong, N.T.
James YW LAU, MD, +852350522640, laujyw@surgery.cuhk.edu.hk
Bing-yee SUEN, MHSc, +85235052640, suenbingyee@surgery.cuhk.edu.hk
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok, Bangkok
Parit Mekaroonkamol, MD
Supakarn Chaithongrat, MD
About this study
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
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.
Read the 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
- Being tested
- The OTSC® System Set, angiographic embolization
- Keywords
- Over-the-scope clips, angiographic embolization
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The OTSC® System SetDevice
The endoscope was extracted and equipped with the OTSC system. OTSC system is deployed on the lesion with suction to target lesion
angiographic embolizationProcedure or surgery
Transcatheter selective embolization to bleeding arteries
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: angiographic embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: within 30 days after randomization
Secondary outcomes (6)
further interventions
repeat endoscopic therapy, interventional radiology or surgery performed for management of further bleeds or a complication of a study intervention
Measured: within 30 days after randomization
blood transfusion
total units of blood transfusion
Measured: within 30 days after randomization
length of hospitalization
duration of hospitalization
Measured: within 30 days after randomization
length of ICU stay
duration of ICU stay
Measured: within 30 days after randomization
mortality related to bleeding
the number of bleeding caused death
Measured: within 30 days after randomization
all cause mortality
the number of death
Measured: within 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start27 Nov 2021
- Primary completion30 Sep 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, MD, Chinese University of Hong Kong
- Investigators
- Yau Wong James Lau, MD, Principal investigator, The Chinese University of HongKong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902248
- Sponsor's protocol ID
- OTSCTAE
- Status last verified
- Mar 2026
- First submitted
- 14 May 2021
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31634917Gralnek 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.
PubMed 26417980Kyaw 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.
PubMed 26134614Beggs 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.
PubMed 24790465Tarasconi 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.
PubMed 30733822Sverden 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.
PubMed 29064894Schmidt 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.
PubMed 29803838