Systematic Description of the Post EMR Defect

NCT03117400 | Completed DMC

• 1 other identifier: HREC/15/5/5.3 (4272)
• Study Type: observational
• Target: 482
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Defect features predicting other adverse events

  day of procedure until 2 weeks after the procedure

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients referred for EMR of a LSL 20mm or larger
• Signed the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Related Publications (1)

• 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.

  PMID: 30503846 DERIVED

Study Officials

• Michael Bourke, MBBS, FRACP

  WSLHD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 18, 2017
• Study Start: May 2, 2013
• Primary Completion: November 1, 2016
• Study Completion: March 30, 2017
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)