Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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/study/NCT03216395
Registration number
NCT03216395
Ethics application status
Date submitted
11/07/2017
Date registered
13/07/2017
Titles & IDs
Public title
Over-the-scope Clips and Standard Treatments in Endoscopic Control of Acute Bleeding From Non-variceal Upper GI Causes
Query!
Scientific title
Over-the-scope Clips and Standard Treatments in Endoscopic Control of of Acute Bleeding From Non-variceal Upper GI Causes(OTSC Study)
Query!
Secondary ID [1]
0
0
Oversco
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Acute Upper Gastrointestinal Bleeding
0
0
Query!
Tumor Bleeding
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Bleeding free probability in 30 days after randomization
Query!
Assessment method [1]
0
0
Further bleeding is defined by failure to control bleeding during first endoscopy or recurrent bleeding after initial control.
Query!
Timepoint [1]
0
0
30 days
Query!
Secondary outcome [1]
0
0
re-interventions in the form of endoscopic
Query!
Assessment method [1]
0
0
heater probe or clips endoscpic therapy
Query!
Timepoint [1]
0
0
30 days
Query!
Secondary outcome [2]
0
0
angiographic treatment
Query!
Assessment method [2]
0
0
angiopgram with embolization to bleeding vessel
Query!
Timepoint [2]
0
0
30 days
Query!
Secondary outcome [3]
0
0
surgical treatment
Query!
Assessment method [3]
0
0
surgical treatment if primary failure or rebleeding
Query!
Timepoint [3]
0
0
30 days
Query!
Secondary outcome [4]
0
0
blood transfusion 4. blood transfusion blood transfusion
Query!
Assessment method [4]
0
0
amount of total blood transfusion
Query!
Timepoint [4]
0
0
30 days
Query!
Secondary outcome [5]
0
0
adverse events
Query!
Assessment method [5]
0
0
adverse events (related or unrelated to endoscopic treatment)
Query!
Timepoint [5]
0
0
30 days
Query!
Secondary outcome [6]
0
0
mortality
Query!
Assessment method [6]
0
0
deaths from all causes
Query!
Timepoint [6]
0
0
30 days
Query!
Secondary outcome [7]
0
0
cost analysis (Based on the cost data from the Hospital
Query!
Assessment method [7]
0
0
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.)
Query!
Timepoint [7]
0
0
30 days
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
111
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/01/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
16/01/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
191
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Sunshine Hospital - Melbourne W.
Query!
Recruitment hospital [2]
0
0
Footscray Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3021 - Melbourne W.
Query!
Recruitment postcode(s) [2]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
China
Query!
State/province [1]
0
0
Beijing
Query!
Country [2]
0
0
China
Query!
State/province [2]
0
0
Jiangsu
Query!
Country [3]
0
0
China
Query!
State/province [3]
0
0
Zhejiang
Query!
Country [4]
0
0
Hong Kong
Query!
State/province [4]
0
0
N.t.
Query!
Country [5]
0
0
Hong Kong
Query!
State/province [5]
0
0
Hong Kong
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Chinese University of Hong Kong
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Queen Mary Hospital, Hong Kong
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
The First Affiliated Hospital of Soochow University
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Other collaborator category [3]
0
0
Other
Query!
Name [3]
0
0
Beijing Friendship Hospital
Query!
Address [3]
0
0
Query!
Country [3]
0
0
Query!
Other collaborator category [4]
0
0
Other
Query!
Name [4]
0
0
Zhejiang University
Query!
Address [4]
0
0
Query!
Country [4]
0
0
Query!
Other collaborator category [5]
0
0
Other
Query!
Name [5]
0
0
Ningbo No. 1 Hospital
Query!
Address [5]
0
0
Query!
Country [5]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03216395
Query!
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. doi: 10.1136/gut.2007.123976. Epub 2007 Jun 12. 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. 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. 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. 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, 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. 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. 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. doi: 10.1053/j.gastro.2003.11.006. http://www.asge.org/uploadedFiles/Publications_(public)/Practice_guidelines/Antithromb otics.pdf 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. Erratum In: Am J Gastroenterol. 2021 Nov 1;116(11):2309. doi: 10.14309/ajg.0000000000001506.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
James LAU, MD
Query!
Address
0
0
CUHK
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03216395