The Use of OTSC in LBGDU to Standard Endoscopic Hemostatic Methods

NCT06196710 | Withdrawn DMC

• 1 other identifier: OTSC-LBGDU
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In managing bleeding gastroduodenal ulcers, endoscopic control of bleeding is the first line treatment-further bleeding after endoscopic hemostasis is associated with a 3-fold increase in mortality. Large ulcer size (\> 20 mm) predicts further bleeding. These ulcers erode into arteries of significant size (\>2 mm) from either the gastro-duodenal or left gastric arterial complexes. An over-the-scope clip is an endoscopic clamp device with a high tensile strength. It can compress sizeable arteries, and firmly anchor onto the ulcer base avoiding recurrent bleeding from clip dislodgement. It therefore offers secure and durable hemostasis. In the proposed randomized controlled trial, the investigators hypothesize that after initial endoscopic control of bleeding from large gastro-duodenal ulcers (20 mm in size or more), adding an OTSC can prevent recurrent bleeding and improve patients' outcomes. Investigators enroll patients with bleeding from large ulcers as defined. After initial endoscopic control of bleeding using injection with diluted epinephrine, these patients are randomized, during endoscopy, to receive standard treatment (thermo-coagulation or hemo-clips) or an added OTSC. The primary endpoint is recurrent bleeding over 30 days confirmed on endoscopy. Secondary endpoints include the need for rescue treatment; endoscopic, angiographic embolization or surgery, red blood cell (RBC) transfusion, hospitalization, and bleeding related and all-cause mortality.

Conditions

Bleeding Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• bleeding free probability in 30 days after randomization

  further bleeding defined by the composite of failure to control bleeding after assigned endoscopic treatment and recurrent bleeding.

  30 days

Secondary Outcomes (4)

• failure to control bleeding with assigned endoscopic treatment and recurrent bleeding after initial hemostasis

  30 days

• number of participants using angiographic treatment

  30 days

• number of participants using surgical treatment

  30 days

• second endoscopic attempts at hemostasis

  30 days

Other Outcomes (4)

• red cell transfusion

  30 days

• number of days in the hospital

  30 days

• number of days in intensive care unit (ICU)

  30 days

Study Arms (2)

Over-the-scope Clips

EXPERIMENTAL

Endoscopic Application of Over-the-scope Clips

Device: Over-the-scope Clips

standard treatment

ACTIVE COMPARATOR

standard treatment of either hemo-clipping or thermo-coagulation with or without pre injection with diluted epinephrine \<=20 clips or pulse

Device: Hemo-clipping

Interventions

Over-the-scope Clips DEVICE

Over-the-scope Clips is mounted onto a transparent cap, which is attached to the tip of the endoscope. To deploy the claw device, a cogwheel at the scope head is turned pulling a trip string. This in turn retracts the cap releasing the OTSC onto the vessels.

Also known as: OTSC

Over-the-scope Clips

Hemo-clipping DEVICE

Contact thermocoagulation using a 3.3mm probe, hemo-clips, or both. The use of the bipolar device involves firm mechanical compression and coagulation for about 8 seconds.

Also known as: quick clips, thermo-coagulation

standard treatment

Eligibility Criteria

• Age: 18 Years - 111 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients admitted with acute upper gastrointestinal bleeding (melena, hematemesis, or decrease in hemoglobin level with or without hypotension).
• large gastro-duodenal ulcers (20 mm in size or more)
• active bleeding (pulsatile or Forrest Ia bleeding, oozing from a visible vessel, or Forrest Ib bleeding) or a nonbleeding visible vessel (Forrest IIa lesion). Clots overlying bleeding lesions are injected with diluted epinephrine and then irrigated or elevated using a cheese-wiring technique. If a vessel is then unveiled, we can proceed with randomization.

You may not qualify if:

• patients with esophagogastric varices
• pregnant or lactating women
• patients who cannot provide written consent
• moribund from their co-morbid illnesses and are not considered for active treatment.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• King Chulalongkorn Memorial Hospital: collaborator
• West China Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator

Related Publications (11)

• 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 BACKGROUND

• Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 Apr 13.

  PMID: 21490373 BACKGROUND

• 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 BACKGROUND

• Jensen DM, Kovacs T, Ghassemi KA, Kaneshiro M, Gornbein J. Randomized Controlled Trial of Over-the-Scope Clip as Initial Treatment of Severe Nonvariceal Upper Gastrointestinal Bleeding. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2315-2323.e2. doi: 10.1016/j.cgh.2020.08.046. Epub 2020 Aug 20.

  PMID: 32828873 BACKGROUND

• Meier B, Wannhoff A, Denzer U, Stathopoulos P, Schumacher B, Albers D, Hoffmeister A, Feisthammel J, Walter B, Meining A, Wedi E, Zachaus M, Pickartz T, Kullmer A, Schmidt A, Caca K. Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2). Gut. 2022 Jul;71(7):1251-1258. doi: 10.1136/gutjnl-2021-325300. Epub 2022 Mar 23.

  PMID: 35321938 BACKGROUND

• Lau JYW, Li R, Tan CH, Sun XJ, Song HJ, Li L, Ji F, Wang BJ, Shi DT, Leung WK, Hartley I, Moss A, Yu KYY, Suen BY, Li P, Chan FKL. Comparison of Over-the-Scope Clips to Standard Endoscopic Treatment as the Initial Treatment in Patients With Bleeding From a Nonvariceal Upper Gastrointestinal Cause : A Randomized Controlled Trial. Ann Intern Med. 2023 Apr;176(4):455-462. doi: 10.7326/M22-1783. Epub 2023 Mar 7.

  PMID: 36877964 BACKGROUND

• Chan S, Pittayanon R, Wang HP, Chen JH, Teoh AY, Kuo YT, Tang RS, Yip HC, Ng SKK, Wong S, Mak JWY, Chan H, Lau L, Lui RN, Wong M, Rerknimitr R, Ng EK, Chiu PWY. Use of over-the-scope clip (OTSC) versus standard therapy for the prevention of rebleeding in large peptic ulcers (size >/=1.5 cm): an open-labelled, multicentre international randomised controlled trial. Gut. 2023 Apr;72(4):638-643. doi: 10.1136/gutjnl-2022-327007. Epub 2022 Oct 28.

  PMID: 36307177 BACKGROUND

• Elmunzer BJ, Young SD, Inadomi JM, Schoenfeld P, Laine L. Systematic review of the predictors of recurrent hemorrhage after endoscopic hemostatic therapy for bleeding peptic ulcers. Am J Gastroenterol. 2008 Oct;103(10):2625-32; quiz 2633. doi: 10.1111/j.1572-0241.2008.02070.x. Epub 2008 Aug 5.

  PMID: 18684171 BACKGROUND

• Vergara M, Bennett C, Calvet X, Gisbert JP. Epinephrine injection versus epinephrine injection and a second endoscopic method in high-risk bleeding ulcers. Cochrane Database Syst Rev. 2014 Oct 13;2014(10):CD005584. doi: 10.1002/14651858.CD005584.pub3.

  PMID: 25308912 BACKGROUND

• Lau JYW, Pittayanon R, Wong KT, Pinjaroen N, Chiu PWY, Rerknimitr R, Holster IL, Kuipers EJ, Wu KC, Au KWL, Chan FKL, Sung JJY. Prophylactic angiographic embolisation after endoscopic control of bleeding to high-risk peptic ulcers: a randomised controlled trial. Gut. 2019 May;68(5):796-803. doi: 10.1136/gutjnl-2018-316074. Epub 2018 May 25.

  PMID: 29802172 BACKGROUND

• Casagrande JT, Pike MC. An improved approximate formula for calculating sample sizes for comparing two binomial distributions. Biometrics. 1978 Sep;34(3):483-6. No abstract available.

  PMID: 719125 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• YUN WONG LAU

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: Patients are randomized in a 1:1 ratio to receive; endoscopic treatment using OTSC or standard therapies.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share