ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12617000530325

Ethics application status

Approved

Date submitted

5/04/2017

Date registered

11/04/2017

Date last updated

14/03/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluation of dynamic clot formation in Endoscopic Mucosal Resection

Scientific title

Evaluation of dynamic clot formation in Endoscopic Mucosal Resection

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

sessile polyp

bleeding

hyperfibrinolysis

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Blood

Clotting disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In theory electro surgery can increase plasminogen activity and cause hyperfibrinolysis..
viscoelastic testing on 3 occasions, which is not part of standard care, might confirm this hypothesis which has not been previously demonstrated in humans.
Viscoelastic testing is assessing whole blood clotting. At our hospital this is done by Thrombelastomerty with ROTEM by our Pathology provider. Only 4 ml of blood is required and the test can be done for up to 4 hours after the sample is taken.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

coagulation abnormality detected by Thrombelastometry

Timepoint [1]

post procedural , before discharge from hospital within 2 hours of EMR, and on day two post EMR

Secondary outcome [1]

bleeding, noted by patient, prompting contacting the hospital and/or re-admission

Timepoint [1]

2-3 days post procedure

Eligibility

Key inclusion criteria

patients undergoing EMR for large sessile colonic polyps

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients on anticoagulants or antiplatelet agents

Study design

Purpose of the study

Diagnosis

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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Analysis will be descriptive

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2017

Actual

19/07/2017

Date of last participant enrolment

Anticipated

31/01/2018

Actual

7/02/2018

Date of last data collection

Anticipated

28/02/2018

Actual

10/02/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment postcode(s) [1]

5112 - Elizabeth Vale

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Anaesthesia research fund

Address [1]

Haydown Rd
Elizabeth Vale
SA 5112

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

South Australian PBM council

Address [2]

11 Hindmarsh Square, Adelaide, SA 5000
Mail: PO Box 287, Rundle Mall, Adelaide SA 5001

Country [2]

Australia

Primary sponsor type

Hospital

Name

Lyell McEwin

Address

Haydown Rd
Elizabeth Vale SA 5112

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (TQEH/LMH/MH)

Ethics committee address [1]

Basil Hetzel Institute 
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/03/2017

Approval date [1]

07/04/2017

Ethics approval number [1]

HREC/17/TQEH/66

Summary

Brief summary

Approximately 17000 colonic cancers are diagnosed in Australia each year. The majority of patients will undergo surgery. Large sessile lesions are traditionally removed surgically. In recent years advances in Endoscopic Mucosal Resection (EMR) emerged as a safe, effective, minimally invasive technique for removal of large sessile polyps and can be performed as an ambulatory procedure in special Gastroenterology units. This has potentially a much smaller impact on the patient and allows a faster recovery.
However, one of the main risk factors of EMR is delayed bleeding. Clinically significant post-endoscopic bleeding [CSPEB] occurred in 6.2% of patients. The underlying cause for the bleeding is unclear.
We suspect that there is a possibility the clotting system gets disturbed slightly during the procedure in some patients. A special blood test looking for clotting abnormalities may help us evaluate if this theory is true or not. 

This study will test for clotting abnormalities before and after endoscopic mucosal resection (EMR).

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and are undergoing EMR for large sessile colonic polyps.

Study details
All participants will have a blood test immediately before and after the EMR to check for clotting abnormalities. Participants will be asked to return to the clinic for post-procedure follow-up 2-3 days after the procedure to determine any occurrences of post-endoscopic bleeding.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Bernd Froessler

Address

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112

Country

Australia

Phone

+61881829806

Fax

bernd.froessler@sa.gov.au

Contact person for public queries

Name

Bernd Froessler

Address

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112

Country

Australia

Phone

+61881829806

Fax

bernd.froessler@sa.gov.au

Contact person for scientific queries

Name

Bernd Froessler

Address

Lyell McEwin Hospital
Haydown Road
Elizabeth Vale SA 5112

Country

Australia

Phone

+61881829806

Fax

bernd.froessler@sa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes			372698-(Uploaded-17-02-2020-16-23-07)-Journal results publication.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Dynamic functional clot formation in patients undergoing endoscopic mucosal resection.	2020	https://dx.doi.org/10.1002/jgh3.12306

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically