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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04008407




Registration number
NCT04008407
Ethics application status
Date submitted
2/07/2019
Date registered
5/07/2019
Date last updated
29/06/2023

Titles & IDs
Public title
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
Scientific title
Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study
Secondary ID [1] 0 0
AU RED HREC/17/WMEAD/497
Universal Trial Number (UTN)
Trial acronym
COVERT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasm 0 0
Endoscopic Mucosal Resection 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic Submucosal Dissection
Treatment: Surgery - Endoscopic Mucosal Resection

Active Comparator: ESD - Lesion with overt stigmata of SMIC or those with high risk (=> 10%) for covert SMIC.

Active Comparator: EMR - Lesion with no overt or a low risk for (<10%) for covert SMIC


Treatment: Surgery: Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection (ESD) results in en-bloc resection of LSL, regardless of lesion size. This allows for accurate histopathological assessment of SMIC, R0/R1 resection and depth of invasion. ESD is considered a potentially curative for superficial cancers (T1a).

Treatment: Surgery: Endoscopic Mucosal Resection
EMR is the current standard for treating colonic LSL and has been validated to be safe and efficacious. LSLs => 20mm are frequently resected piecemeal. Recent research show that resection margin soft coagulation reduces recurrence rates to those similar to en-bloc resections.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of surgical referral
Timepoint [1] 0 0
3 months post procedure
Secondary outcome [1] 0 0
R0 resection rate
Timepoint [1] 0 0
3 months post procedure
Secondary outcome [2] 0 0
En Bloc resection rate
Timepoint [2] 0 0
3 months post procedure
Secondary outcome [3] 0 0
Technical success rate
Timepoint [3] 0 0
3 months post procedure
Secondary outcome [4] 0 0
Duration of procedure
Timepoint [4] 0 0
procedure
Secondary outcome [5] 0 0
Adenoma recurrence rate
Timepoint [5] 0 0
3 years post procedure

Eligibility
Key inclusion criteria
- All patients referred for colorectal resection of large laterally spreading lesions in
colon.

- Can give informed consent to trial participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous resection or attempted resection of target adenoma lesion

- Endoscopic appearance of invasive malignancy

- Age less than 18 years

- Pregnancy

- Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)

- Use of anticoagulant or antiplatelet agents other than aspirin outside of
internationally recognised guidelines

- American Society of Anesthesiology (ASA) Grade IV-V

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/08/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2028
Actual
Sample size
Target
391
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Endoscopy Unit - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Colonic Laterally spreading lesions (LSL) => 20mm are at high risk to progress to cancer.
Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes
ulceration and surface pit pattern changes as per the Kudo classification of type V.

In a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC)
were described. Resection of these lesions 'en-bloc' can allow for better histological
staging and potentially reduce the need for surgical resection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04008407
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael J Bourke, Prof.
Address 0 0
Country 0 0
Phone 0 0
+61288905555
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04008407