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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04008407
Ethics application status
Date submitted
2/07/2019
Date registered
5/07/2019

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
Trial website
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
endoscopyresearch.westmead@gmail.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb... [More Details]
Journal Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogela... [More Details]
Journal Iishi H, Tatsuta M, Iseki K, Narahara H, Uedo N, S... [More Details]
Journal Risio M. The natural history of colorectal adenoma... [More Details]
Journal Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown... [More Details]
Journal Nanda KS, Tutticci N, Burgess NG, Sonson R, Willia... [More Details]
Journal Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikemat... [More Details]
Journal Lee EJ, Lee JB, Lee SH, Youk EG. Endoscopic treatm... [More Details]
Journal Terasaki M, Tanaka S, Oka S, Nakadoi K, Takata S, ... [More Details]
Journal Burgess NG, Hourigan LF, Zanati SA, Brown GJ, Sing... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT04008407