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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
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
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
re-interventions in the form of endoscopic
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
angiographic treatment
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
surgical treatment
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
blood transfusion 4. blood transfusion blood transfusion
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
adverse events
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
mortality
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
cost analysis (Based on the cost data from the Hospital
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
Sex
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
Completed
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
Trial website
Trial related presentations / publications
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.