- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03117400
Systematic Description of the Post EMR Defect
Visible Vessels do Not Predict Clinically Significant Bleeding After EMR - a Systematic Description of the Post EMR Defect
To date there are no available data on the utility of the endoscopic mucosal resection (EMR) defect in stratifying the risk of immediate or delayed adverse outcomes, particularly clinically significant post EMR bleeding (CSPEB).
The investigators aimed to analyse the data to determine if any of these EMR defect features allow us to estimate the risk of CSPEB. This will help endoscopists to identify defects with a high risk of adverse outcomes and may translate into improved patient outcomes.
Study Overview
Status
Detailed Description
CSPEB is the most frequent serious complication after wide-field EMR of laterally spreading lesions ≥ 20mm (LSLs). There is no proven therapy for CSPEB and it remains a significant drawback of EMR. Visible vessels within the post EMR defect (PED) present themselves as logical targets for prophylactic treatment to prevent CSPEB. However, the clinical significance of these vessels is largely unknown. In the majority of studies risk factors identified for CSPEB include right colon location, lesion size and aspirin use. The investigators aimed to systematically describe and evaluate the clinical significance of the various endoscopic features of the post EMR defect PED including visible vessels.
A prospective study of LSLs ≥ 20mm referred for EMR at a single tertiary referral center will be performed.
Data collection includes patient, procedural and lesion characteristics. In all cases a systematic description of the PED is undertaken. The data of particular interest to this study includes: use of blood thinners, PED features including size, number and herniation of visible vessels, submucosal haemorrhage, fibrosis, fat and exposed muscle and the rate of CSPEB.These features were analysed for significant association with CSPEB. CSPEB was defined as any bleeding occurring after the completion of the procedure necessitating emergency department presentation, hospitalization or reintervention. CSPEB was compared to features of the PED to detect significant associations, using chi2 or Fisher's exact tests. Significant univariate variables will be taken forward for binomial logistic regression modelling.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New South Wales
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Westmead, New South Wales, Australia, 2145
- Westmead Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients referred for EMR of a LSL 20mm or larger
- Signed the informed consent
Exclusion Criteria:
- Clips used during the EMR procedure to close the defect, totally or partially
- Inadequate images to adequately assess the defect
- Use of blood thinners which have not been ceased according to the current guidelines for EMR
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Bland blue defect
The defect after endoscopic mucosal resection of the colonic large laterally spreading lesion (20mm or more) is blue without any other defect features (as described in the second group, 'non bland blue defect').
The blue is the result of the submucosal injection of dye (indigo carmine), used to lift lesions before starting the resection.
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Non bland blue defect
The defect after endoscopic mucosal resection of the colonic large laterally spreading lesion (20mm or more) is not just blue, but contains other defect features, such as visible vessels, herniation of vessels, submucosal fat, exposed muscle, fibrous bands, submucosal haemorrhage or non stained submucosa.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defect features predicting clinically significant post EMR bleeding
Time Frame: day of procedure until 2 weeks after the procedure
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To assess if any of the defect features can predict clinically significant post EMR bleeding
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day of procedure until 2 weeks after the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defect features predicting other adverse events
Time Frame: day of procedure until 2 weeks after the procedure
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To assess if any of the defect features can predict perforation or recurrence
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day of procedure until 2 weeks after the procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Michael Bourke, MBBS, FRACP, WSLHD
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HREC/15/5/5.3 (4272)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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