Over-the-scope Clips and Standard Treatments in Endoscopic Control of Acute Bleeding From Non-variceal Upper GI Causes

NCT03216395 | Completed DMC

• 1 other identifier: Oversco
• Study Type: interventional
• Target: 191
• Locations: 3 countries
• Sites: 8

Brief Summary

In the management of patients with acute upper gastrointestinal bleeding from non-variceal causes, endoscopic treatment and acid suppression are now the standard of care. Current endoscopic treatment in the form of either thermo-coagulation or clipping to the bleeding arteries is highly efficacious in the stopping bleeding. Unfortunately in 5 to 10% of patients, bleeding cannot be controlled during index endoscopy or recurs after initial hemostasis. These patients are often elderly with significant co-morbidities. Their bleeding lesions are large eroding into major sub-serosal arteries. In the few who need surgical salvage, mortality increases to around 30%. The Over-the-scope-Clip (OTSC) is a device, which allows endoscopists to capture a large amount of tissue and compress on the bleeding artery. The OTSC also has a high retention rate. Recurrent bleeding with the use of standard hemo-clips can occur because of their low retention rate. We reported the use of OTSC with a high success rate in a case series of patients with refractory bleeding after standard endoscopic treatment. We have also used OTSC in the treatment of bleeding from pseudo-aneurysm arising from large eroded arteries in ulcer base. A multicenter randomized controlled trial that compares OTSC to standard endoscopic treatment in the endoscopic treatment of refractory bleeding lesions has just been completed. The use of OTSC has been shown to be superior in achieving hemostatic control and reducing further bleeding. In this proposed randomized controlled trial, we would test the hypothesis that the use of OTSC, when used as the first or primary treatment, is superior to standard treatment in achieving hemostasis and thereby improve patients' outcomes.

Conditions

Acute Upper Gastrointestinal Bleeding; Tumor Bleeding

Outcome Measures

Primary Outcomes (1)

• Bleeding free probability in 30 days after randomization

  Further bleeding is defined by failure to control bleeding during first endoscopy or recurrent bleeding after initial control.

  30 days

Secondary Outcomes (7)

• re-interventions in the form of endoscopic

  30 days

• angiographic treatment

  30 days

• surgical treatment

  30 days

• blood transfusion 4. blood transfusion blood transfusion

  30 days

• adverse events

  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; Device: thermo-coagulation; Drug: Epinephrine

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 tissue.

Also known as: OTSC

Over-the-scope Clips

Hemo-clipping DEVICE

Hemo-clipping \<=20 clips

Also known as: quick clips

standard treatment

thermo-coagulation DEVICE

contact thermo-coagulation \< = 8 pulses

Also known as: contact thermo-coagulation

standard treatment

Epinephrine DRUG

epinephrine injection (diluted 1:1000) beneath peptic ulcer \<20 mls

Also known as: adrenaline

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 with overt signs of acute upper GIB (melena, hematemesis, drop in hemoglobin with or without hypotension)
• documented bleeding lesions suitable for standard endoscopic treatment during endoscopy

You may not qualify if:

• without a full informed consent from the patient or his legally-acceptable representatives
• Age \<18 years
• Pregnant
• Lactating women
• Moribund patients not considered for active treatment.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Beijing Friendship Hospital: collaborator
• Zhejiang University: collaborator
• Ningbo No. 1 Hospital: collaborator

Study Sites (8)

Footscray Hospital

Melbourne, Victoria, Australia

Location

Sunshine Hospital

Melbourne W., Victoria, 3021, Australia

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Location

The First Affliated Hospital of SooChow University

Suzhou, Jiangsu, China

Location

The First Affliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Location

Ningbo First Hospital

Ningbo, Zhejiang, China

Location

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, N.T., Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (14)

• 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

• Sung JJ, Tsoi KK, Lai LH, Wu JC, Lau JY. Endoscopic clipping versus injection and thermo-coagulation in the treatment of non-variceal upper gastrointestinal bleeding: a meta-analysis. Gut. 2007 Oct;56(10):1364-73. doi: 10.1136/gut.2007.123976. Epub 2007 Jun 12.

  PMID: 17566018 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

• Johnston JH, Jensen DM, Auth D. Experimental comparison of endoscopic yttrium-aluminum-garnet laser, electrosurgery, and heater probe for canine gut arterial coagulation. Importance of compression and avoidance of erosion. Gastroenterology. 1987 May;92(5 Pt 1):1101-8. doi: 10.1016/s0016-5085(87)91065-1.

  PMID: 3493938 BACKGROUND

• Swain CP, Storey DW, Bown SG, Heath J, Mills TN, Salmon PR, Northfield TC, Kirkham JS, O'Sullivan JP. Nature of the bleeding vessel in recurrently bleeding gastric ulcers. Gastroenterology. 1986 Mar;90(3):595-608. doi: 10.1016/0016-5085(86)91113-3.

  PMID: 3943691 BACKGROUND

• Swain CP, Lai KC, Kalabakas A, Grandison A, Pollock D. A comparison of size and pathology of vessel and ulcer in patients dying from bleeding gastric and duodenal ulcers. Gastroenterology 1993;104:suppl:A202.

  BACKGROUND

• Manno M, Mangiafico S, Caruso A, Barbera C, Bertani H, Mirante VG, Pigo F, Amardeep K, Conigliaro R. First-line endoscopic treatment with OTSC in patients with high-risk non-variceal upper gastrointestinal bleeding: preliminary experience in 40 cases. Surg Endosc. 2016 May;30(5):2026-9. doi: 10.1007/s00464-015-4436-y. Epub 2015 Jul 23.

  PMID: 26201415 BACKGROUND

• Monkemuller K, Toshniwal J, Zabielski M, Vormbrock K, Neumann H. Utility of the "bear claw", or over-the-scope clip (OTSC) system, to provide endoscopic hemostasis for bleeding posterior duodenal ulcers. Endoscopy. 2012;44 Suppl 2 UCTN:E412-3. doi: 10.1055/s-0032-1325737. Epub 2012 Nov 20. No abstract available.

  PMID: 23169041 BACKGROUND

• Chan SM, Chiu PW, Teoh AY, Lau JY. Use of the Over-The-Scope Clip for treatment of refractory upper gastrointestinal bleeding: a case series. Endoscopy. 2014 May;46(5):428-31. doi: 10.1055/s-0034-1364932. Epub 2014 Feb 6.

  PMID: 24505017 BACKGROUND

• Schmidt A, Goelder S, Messmann H, Goetz M, Kratt T, Meining A, Birk M, von Delius S, Albert J, Escher M, Lau JY, Hoffman A, Wiest R, Caca K, Over-the-scope-clips versus standard endoscopic therapy in patients with recurrent peptic ulcer bleeding-preliminary results of a prospective randomized, multicenter trial ("STING") (unpublished data)

  BACKGROUND

• Calvet X, Vergara M, Brullet E, Gisbert JP, Campo R. Addition of a second endoscopic treatment following epinephrine injection improves outcome in high-risk bleeding ulcers. Gastroenterology. 2004 Feb;126(2):441-50. doi: 10.1053/j.gastro.2003.11.006.

  PMID: 14762781 BACKGROUND

• http://www.asge.org/uploadedFiles/Publications_(public)/Practice_guidelines/Antithromb otics.pdf

  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 DERIVED

• Laine L, Barkun AN, Saltzman JR, Martel M, Leontiadis GI. ACG Clinical Guideline: Upper Gastrointestinal and Ulcer Bleeding. Am J Gastroenterol. 2021 May 1;116(5):899-917. doi: 10.14309/ajg.0000000000001245.

  PMID: 33929377 DERIVED

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• James LAU, MD

  CUHK

  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 Stratified randomization according to size of ulcers and non-ulcer lesions 1. size smaller than10mm in diameter 2. size equal to 10mm and less than 20mm in diameter 3. size equal or greater than 20mm in diameter 4. non-ulcer lesions

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: January 2, 2018
• Primary Completion: January 16, 2021
• Study Completion: January 16, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4); AU (2); HK (2)