Clinical trial NCT03117400: Systematic Description of the Post EMR Defect
Official title: Visible Vessels do Not Predict Clinically Significant Bleeding After EMR - a Systematic Description of the Post EMR Defect
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delayed Bleeding Post EMR
Large Laterally Spreading Lesion in the Colon
Endoscopic Mucosal Resection
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 482
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Defect features predicting clinically significant post EMR bleeding
timeFrame: day of procedure until 2 weeks after the procedure
Secondary outcomes:
measure: Defect features predicting other adverse events
timeFrame: day of procedure until 2 weeks after the procedure
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
affiliation: WSLHD
name: Michael Bourke, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.