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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03117400

Enrollment

482

Registered

2017-04-18

Start date

2013-05-02

Completion date

2017-03-30

Last updated

2023-06-29

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

Conditions

Delayed Bleeding Post EMR, Endoscopic Mucosal Resection, Large Laterally Spreading Lesion in the Colon

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Defect features predicting clinically significant post EMR bleeding	day of procedure until 2 weeks after the procedure	To assess if any of the defect features can predict clinically significant post EMR bleeding

Secondary

Measure	Time frame	Description
Defect features predicting other adverse events	day of procedure until 2 weeks after the procedure	To assess if any of the defect features can predict perforation or recurrence

Countries

Australia

Outcome results