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Trial registered on ANZCTR


Registration number
ACTRN12620000245998p
Ethics application status
Submitted, not yet approved
Date submitted
4/02/2020
Date registered
26/02/2020
Date last updated
26/02/2020
Date data sharing statement initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Haemostatic Gel Prophylaxis for Post Colorectal Endoscopic Resection Bleeding: Observational Study
Scientific title
Haemostatic Gel Prophylaxis for Post Colorectal Endoscopic Resection Bleeding: Observational Study
Secondary ID [1] 300070 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal advanced mucosal neoplasia 315591 0
Condition category
Condition code
Oral and Gastrointestinal 313879 313879 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 314502 314502 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Advanced endoscopic resection techniques such as Endoscopic Mucosal Resection (EMR) have provided a minimally invasive alternative to surgery for curative management of advanced mucosal neoplasia. The safety profile and outcomes of EMR techniques are significantly better than surgical resection however significant post resection bleeding remains an ongoing challenge. There is currently no consistently recommended strategy to reduce the risk of post-EMR bleeding that has been adopted as standard of care. In particular, patients on antithrombotic therapy are at high risk of post procedure bleeding and strategies to mitigate this are required.
A recently introduced haemostatic gel (Purastat, 3D-Matrix) that acts as a self assembling nanoparticle matrix has demonstrated efficacy as a topical haemostat in controlling oozing bleeding in a number of anatomical locations including applications in ENT, Gynaecology, and endoscopy.
The haemostatic gel will be applied to the post EMR mucosal defect to consecutive eligible, consenting patients undergoing endoscopic mucosal resection who are on anti-thrombotic therapy (excluding single agent aspirin) or multiple agents. We will be applying aliquots of 1-5mLs of the gel matrix; the exact amount will be determined by the size of the defect remaining post excision of the target lesion. Gel will be applied endoscopically at the time of the procedure via the proceduralist until the entire defect has been covered - this is considered the one and only time the gel will be delivered.
Intervention code [1] 316337 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322269 0
Rate of clinically significant post-procedural bleeding requiring further intervention (such as blood transfusion, admission to hospital, or other blood products (such as platelets, fresh frozen plasma, prothrombinex)
This will be assessed clinically by the presence of gastrointestinal bleeding (such as per-rectal bleeding) where patients were given blood products as documented in the medical record.
Timepoint [1] 322269 0
30 days post endoscopic procedure
Secondary outcome [1] 377957 0
Procedure related adverse events. This is a composite of
- delayed perforation (as identified on imaging such as CT or MRI, or surgically)
- procedure related hospitalisation
- Procedure related death (where the death is a direct result of the procedure or a complication of the procedure)
These will be assessed via review of the medical record for documented evidence of any of the adverse events mentioned above.
Timepoint [1] 377957 0
30 days post endoscopic procedure
Secondary outcome [2] 378014 0
Procedure outcome (successful EMR) - as determined by the proceduralist as complete resection of the target lesion(s). This is determined at the time of the procedure by the endoscopist and will be documented in the procedure report.
Timepoint [2] 378014 0
30 days post endoscopic procedure
Secondary outcome [3] 380179 0
Haemostatic gel measure;
- volume of gel applied

This will be the total volume of gel (mLs) applied during the procedure and this may be corrected for the size of the defect (mLs per squared centimentre). These measures will be provided in the procedure report.
Timepoint [3] 380179 0
Day of procedure (day 0)
Secondary outcome [4] 380180 0
Haemostatic gel measures;
- time of gel being applied +/- sec/mL of gel

This will be the total time that was needed to apply the gel during the endoscopic procedure, measured in seconds. This may be corrected for the amount of gel applied (seconds per mL). These measures will be provided in the procedure report.
Timepoint [4] 380180 0
Day of procedure (day 0)
Secondary outcome [5] 380181 0
Haemostatic gel measures;
- successful application to entire post-EMR defects

Binary (yes/no outcome) as determined by the endoscopist at the time of the procedure and documented in the procedure report.
Timepoint [5] 380181 0
Day of procedure (day 0)

Eligibility
Key inclusion criteria
Colorectal lesions
Size 20mm and above
3 or less lesions per patient
Single agent (excluding aspirin) or multiple anti-thrombotic agent use ceased within 1 week before the procedure and resumed within 5 days after EMR
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent
• Age <18 years old
• Pregnant
• Allergy to Purastat
• “Cold” endoscopic mucosal resection

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
100 consecutive patients across multiple sites
Descriptive statistics
Chi-squared for categorical data
Student's t-test for comparing means
Univariate and subsequent multi-variate analysis of pre-determined variables on the outcomes of interest

Recruitment
Recruitment status
Not yet recruiting
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)
NSW,QLD,WA,VIC
Recruitment hospital [1] 15502 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 15503 0
Liverpool Day Surgery - Moorebank
Recruitment hospital [3] 15504 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [4] 15505 0
Port Macquarie Private Hospital - Port Macquarie
Recruitment hospital [5] 15506 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 15507 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 15508 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [8] 15509 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [9] 15510 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [10] 15511 0
Concord Repatriation Hospital - Concord
Recruitment hospital [11] 15512 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 28866 0
2076 - Wahroonga
Recruitment postcode(s) [2] 28865 0
2139 - Concord
Recruitment postcode(s) [3] 28857 0
2170 - Liverpool
Recruitment postcode(s) [4] 28858 0
2170 - Moorebank
Recruitment postcode(s) [5] 28859 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 28863 0
3050 - Parkville
Recruitment postcode(s) [7] 28864 0
3065 - Fitzroy
Recruitment postcode(s) [8] 28862 0
4029 - Herston
Recruitment postcode(s) [9] 28860 0
4215 - Southport
Recruitment postcode(s) [10] 28861 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 304519 0
Hospital
Name [1] 304519 0
Liverpool Hospital Gastroenterology Department
Address [1] 304519 0
Cnr Elizabeth and Goulburn St, Liverpool, NSW, 2170
Country [1] 304519 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Cnr Elizabeth and Goulburn St, Liverpool, NSW, 2170
Country
Australia
Secondary sponsor category [1] 304790 0
None
Name [1] 304790 0
Address [1] 304790 0
Country [1] 304790 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304950 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304950 0
Cnr Elizabeth and Goulburn St, Liverpool, NSW, 2170
Ethics committee country [1] 304950 0
Australia
Date submitted for ethics approval [1] 304950 0
06/02/2020
Approval date [1] 304950 0
Ethics approval number [1] 304950 0

Summary
Brief summary
The purpose of this study is to test a gel with blood-controlling properties called Purastat. This gel may be useful because bleeding a risk after endoscopy, especially if the patient uses anti-clotting medications

Who is it for?
You may be eligible for this study if you are aged over 18, are undergoing an endoscopic resection procedure for colorectal lesions and use an anti-clotting medication.

Study details
All participants in this study will undergo their procedure as scheduled. During the procedure the endoscopist will apply a few millilitres of the Purastat gel to the site of the resection. The procedure will otherwise be a per standard procedures. There will be no additional requirements from patients as part of this study – all patients will have routine care post-procedure.

It is hypothesised this gel will reduce the rate of post-resection bleeding and improve outcomes for patients at risk of bleeding after endoscopic resections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98742 0
Dr Milan Bassan
Address 98742 0
Liverpool Hospital, Cnr Elizabeth and Goulburn St, Liverpool NSW, 2170
Country 98742 0
Australia
Phone 98742 0
+61 02 9601 7766
Fax 98742 0
Email 98742 0
milan.bassan@gmail.com
Contact person for public queries
Name 98743 0
Dr Martin Harb
Address 98743 0
Liverpool Hospital, Cnr Elizabeth and Goulburn St, Liverpool NSW, 2170
Country 98743 0
Australia
Phone 98743 0
+61 02 9601 7766
Fax 98743 0
Email 98743 0
martin.harb@health.nsw.gov.au
Contact person for scientific queries
Name 98744 0
Dr Martin Harb
Address 98744 0
Liverpool Hospital, Cnr Elizabeth and Goulburn St, Liverpool NSW, 2170
Country 98744 0
Australia
Phone 98744 0
+61 02 9601 7766
Fax 98744 0
Email 98744 0
martin.harb@health.nsw.gov.au

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?
Study protocol
How or where can supporting documents be obtained?
Type [1] 6183 0
Study protocol
Citation [1] 6183 0
Link [1] 6183 0
Email [1] 6183 0
Other [1] 6183 0
Summary results
No Results