The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03216395




Registration number
NCT03216395
Ethics application status
Date submitted
11/07/2017
Date registered
13/07/2017
Date last updated
30/06/2020

Titles & IDs
Public title
Over-the-scope Clips and Standard Treatments in Endoscopic Control of Acute Bleeding From Non-variceal Upper GI Causes
Scientific title
Over-the-scope Clips and Standard Treatments in Endoscopic Control of of Acute Bleeding From Non-variceal Upper GI Causes(OTSC Study)
Secondary ID [1] 0 0
Oversco
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Upper Gastrointestinal Bleeding 0 0
Tumor Bleeding 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Over-the-scope Clips
Treatment: Devices - Hemo-clipping
Treatment: Devices - thermo-coagulation
Treatment: Drugs - Epinephrine

Experimental: Over-the-scope Clips - Endoscopic Application of Over-the-scope Clips

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


Treatment: Devices: Over-the-scope Clips
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.

Treatment: Devices: Hemo-clipping
Hemo-clipping <=20 clips

Treatment: Devices: thermo-coagulation
contact thermo-coagulation < = 8 pulses

Treatment: Drugs: Epinephrine
epinephrine injection (diluted 1:1000) beneath peptic ulcer <20 mls

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
re-interventions in the form of endoscopic - heater probe or clips endoscpic therapy
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
angiographic treatment - angiopgram with embolization to bleeding vessel
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
surgical treatment - surgical treatment if primary failure or rebleeding
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
blood transfusion 4. blood transfusion blood transfusion - amount of total blood transfusion
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
adverse events - adverse events (related or unrelated to endoscopic treatment)
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
mortality - deaths from all causes
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
cost analysis (Based on the cost data from the Hospital - Authority Gazette, Hong Kong Special Administrative Region Government; the investigator will calculate cost to avert one episode of further clinical bleeding with the use of OTSC or standard treatment. A series of sensitivity analyses varying device costs and over a range of re-bleeding rates.)
Timepoint [7] 0 0
30 days

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
111 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Sunshine Hospital - Melbourne W.
Recruitment hospital [2] 0 0
Footscray Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3021 - Melbourne W.
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Jiangsu
Country [3] 0 0
China
State/province [3] 0 0
Zhejiang
Country [4] 0 0
Hong Kong
State/province [4] 0 0
N.t.
Country [5] 0 0
Hong Kong
State/province [5] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Other
Name
Chinese University of Hong Kong
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queen Mary Hospital, Hong Kong
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The First Affiliated Hospital of Soochow University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Beijing Friendship Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Zhejiang University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Ningbo No. 1 Hospital
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03216395
Trial related presentations / publications
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.
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. Epub 2007 Jun 12. Review.
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. Review.
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.
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.
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.
Manno M, Mangiafico S, Caruso A, Barbera C, Bertani H, Mirante VG, Pigò 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.
Mönkemüller 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.
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.
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)
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. Review.
http://www.asge.org/uploadedFiles/Publications_(public)/Practice_guidelines/Antithromb otics.pdf
Public notes

Contacts
Principal investigator
Name 0 0
James LAU, MD
Address 0 0
CUHK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
James LAU, MD
Address 0 0
Country 0 0
Phone 0 0
+85235051411
Fax 0 0
Email 0 0
laujyw@surgery.cuhk.edu.hk
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03216395