Evaluation of dynamic clot formation in Endoscopic Mucosal Resection

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000530325

Enrollment

Registered

2017-04-11

Start date

2017-07-19

Completion date

2018-02-07

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

patients undergoing EMR for large sessile colonic polyps

Exclusion criteria

Patients on anticoagulants or antiplatelet agents

Outcome results