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OpenTrials
Completed

NCT Number: NCT03117400

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Defect features predicting clinically significant post EMR bleeding

    Time frame: 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 outcomes

  1. Defect features predicting other adverse events

    Time frame: day of procedure until 2 weeks after the procedure

    To assess if any of the defect features can predict perforation or recurrence

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Official study title

Visible Vessels do Not Predict Clinically Significant Bleeding After EMR - a Systematic Description of the Post EMR Defect

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Apr 18, 2017
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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