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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]

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

Endoscopic Mucosal Resection

Condition category

Condition code

Cancer

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]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Rate of surgical referral

Timepoint [1]

3 months post procedure

Secondary outcome [1]

R0 resection rate

Timepoint [1]

3 months post procedure

Secondary outcome [2]

En Bloc resection rate

Timepoint [2]

3 months post procedure

Secondary outcome [3]

Technical success rate

Timepoint [3]

3 months post procedure

Secondary outcome [4]

Duration of procedure

Timepoint [4]

procedure

Secondary outcome [5]

Adenoma recurrence rate

Timepoint [5]

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?

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

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]

Westmead Endoscopy Unit - Westmead

Recruitment postcode(s) [1]

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/study/NCT04008407

Trial related presentations / publications

Winawer SJ, Zauber AG, Ho MN, O'Brien MJ, Gottlieb LS, Sternberg SS, Waye JD, Schapiro M, Bond JH, Panish JF, et al. Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup. N Engl J Med. 1993 Dec 30;329(27):1977-81. doi: 10.1056/NEJM199312303292701.
Zauber AG, Winawer SJ, O'Brien MJ, Lansdorp-Vogelaar I, van Ballegooijen M, Hankey BF, Shi W, Bond JH, Schapiro M, Panish JF, Stewart ET, Waye JD. Colonoscopic polypectomy and long-term prevention of colorectal-cancer deaths. N Engl J Med. 2012 Feb 23;366(8):687-96. doi: 10.1056/NEJMoa1100370.
Iishi H, Tatsuta M, Iseki K, Narahara H, Uedo N, Sakai N, Ishikawa H, Otani T, Ishiguro S. Endoscopic piecemeal resection with submucosal saline injection of large sessile colorectal polyps. Gastrointest Endosc. 2000 Jun;51(6):697-700. doi: 10.1067/mge.2000.104652.
Risio M. The natural history of colorectal adenomas and early cancer. Pathologe. 2012 Nov;33 Suppl 2:206-10. doi: 10.1007/s00292-012-1640-6.
Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.
Nanda KS, Tutticci N, Burgess NG, Sonson R, Williams SJ, Bourke MJ. Endoscopic mucosal resection of laterally spreading lesions involving the ileocecal valve: technique, risk factors for failure, and outcomes. Endoscopy. 2015 Aug;47(8):710-8. doi: 10.1055/s-0034-1391732. Epub 2015 Mar 12.
Oka S, Tanaka S, Saito Y, Iishi H, Kudo SE, Ikematsu H, Igarashi M, Saitoh Y, Inoue Y, Kobayashi K, Hisabe T, Tsuruta O, Sano Y, Yamano H, Shimizu S, Yahagi N, Watanabe T, Nakamura H, Fujii T, Ishikawa H, Sugihara K; Colorectal Endoscopic Resection Standardization Implementation Working Group of the Japanese Society for Cancer of the Colon and Rectum, Tokyo, Japan. Local recurrence after endoscopic resection for large colorectal neoplasia: a multicenter prospective study in Japan. Am J Gastroenterol. 2015 May;110(5):697-707. doi: 10.1038/ajg.2015.96. Epub 2015 Apr 7.
Lee EJ, Lee JB, Lee SH, Youk EG. Endoscopic treatment of large colorectal tumors: comparison of endoscopic mucosal resection, endoscopic mucosal resection-precutting, and endoscopic submucosal dissection. Surg Endosc. 2012 Aug;26(8):2220-30. doi: 10.1007/s00464-012-2164-0. Epub 2012 Jan 26.
Terasaki M, Tanaka S, Oka S, Nakadoi K, Takata S, Kanao H, Yoshida S, Chayama K. Clinical outcomes of endoscopic submucosal dissection and endoscopic mucosal resection for laterally spreading tumors larger than 20 mm. J Gastroenterol Hepatol. 2012 Apr;27(4):734-40. doi: 10.1111/j.1440-1746.2011.06977.x.
Burgess NG, Hourigan LF, Zanati SA, Brown GJ, Singh R, Williams SJ, Raftopoulos SC, Ormonde D, Moss A, Byth K, Mahajan H, McLeod D, Bourke MJ. Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort. Gastroenterology. 2017 Sep;153(3):732-742.e1. doi: 10.1053/j.gastro.2017.05.047. Epub 2017 Jun 2.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Michael J Bourke, Prof.

Address

Country

Phone

+61288905555

Fax

[email protected]

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

Type	Citations 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

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