Delayed Bleeding Post EMRNCT03117400
Systematic Description of the Post EMR Defect
An observational study of Delayed Bleeding Post EMR and Large Laterally Spreading Lesion in the Colon, run by Western Sydney Local Health District at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delayed Bleeding Post EMR, Large Laterally Spreading Lesion in the Colon, Endoscopic Mucosal Resection
- Type of treatment
- Injection or infusion
- How many people
- 482 participants
- Where
- 1 siteAustralia
- Study dates
- 2 May 2013to 30 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients with a colonic laterally spreading lesion ≥ 20mm referred for EMR at a single tertiary referral centre will be included.
Who may be able to join
- All patients referred for EMR of a LSL 20mm or larger
- Signed the informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Defect features predicting clinically significant post EMR bleeding
To assess if any of the defect features can predict clinically significant post EMR bleeding
Measured: day of procedure until 2 weeks after the procedure
Secondary outcomes (1)
Defect features predicting other adverse events
To assess if any of the defect features can predict perforation or recurrence
Measured: day of procedure until 2 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start2 May 2013
- Primary completionNov 2016
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Bleeding Post EMRStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Michael Bourke, Western Sydney Local Health District
- Investigators
- Michael Bourke, MBBS, FRACP, Principal investigator, WSLHD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117400
- Sponsor's protocol ID
- HREC/15/5/5.3 (4272)
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30503846
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visible Vessels do Not Predict Clinically Significant Bleeding After EMR - a Systematic Description of the Post EMR Defect
- ClinicalTrials.gov ID
- NCT03117400
- Acronym / sponsor ID
- HREC/15/5/5.3 (4272)
- Conditions
- Delayed Bleeding Post EMR, Large Laterally Spreading Lesion in the Colon, Endoscopic Mucosal Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 2 May 2013 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with a colonic laterally spreading lesion ≥ 20mm referred for EMR at a single tertiary referral centre will be included.
Key inclusion criteria (2 listed)
- All patients referred for EMR of a LSL 20mm or larger
- Signed the informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Defect features predicting other adverse events
Time frame: day of procedure until 2 weeks after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 30503846Desomer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bourke, MBBS, FRACP principal investigator
WSLHD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Bleeding Post EMR and Large Laterally Spreading Lesion in the Colon, run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defect features predicting clinically significant post EMR bleeding (time frame: day of procedure until 2 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03117400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.