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: Completed
• Conditions: Endoscopic Mucosal Resection; Delayed Bleeding Post EMR; Large Laterally Spreading Lesion in the Colon

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: Observational
• Enrollment (Actual): 482

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with a colonic laterally spreading lesion ≥ 20mm referred for EMR at a single tertiary referral centre will be included.

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Western Sydney Local Health District
• Investigators: Principal Investigator: Michael Bourke, MBBS, FRACP, WSLHD

Publications and helpful links

General Publications

• Desomer L, Tate DJ, Bahin FF, Awadie H, Chiang B, Holt B, Byth K, Bourke MJ. A systematic description of the post-EMR defect to identify risk factors for clinically significant post-EMR bleeding in the colon. Gastrointest Endosc. 2019 Mar;89(3):614-624. doi: 10.1016/j.gie.2018.11.023. Epub 2018 Nov 29.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: HREC/15/5/5.3 (4272)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No