ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study

NCT04008407 | Recruiting

• 1 other identifier: AU RED HREC/17/WMEAD/497
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasm; Endoscopic Mucosal Resection

Outcome Measures

Primary Outcomes (1)

• Rate of surgical referral

  Incidence of surgical referral due to non-curative endoscopic resection.

  3 months post procedure

Secondary Outcomes (5)

• R0 resection rate

  3 months post procedure

• En Bloc resection rate

  3 months post procedure

• Technical success rate

  3 months post procedure

• Duration of procedure

  procedure

• Adenoma recurrence rate

  3 years post procedure

Study Arms (2)

ESD

ACTIVE COMPARATOR

Lesion with overt stigmata of SMIC or those with high risk (=\> 10%) for covert SMIC.

Procedure: Endoscopic Submucosal Dissection

EMR

ACTIVE COMPARATOR

Lesion with no overt or a low risk for (\<10%) for covert SMIC

Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Submucosal Dissection PROCEDURE

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).

Also known as: ESD

ESD

Endoscopic Mucosal Resection PROCEDURE

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.

Also known as: EMR

EMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients referred for colorectal resection of large laterally spreading lesions in colon.
• Can give informed consent to trial participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

RECRUITING

Related Publications (10)

• 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.

  PMID: 8247072 RESULT

• 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.

  PMID: 22356322 RESULT

• 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.

  PMID: 10840302 RESULT

• 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.

  PMID: 22945585 RESULT

• 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.

  PMID: 21392504 RESULT

• 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.

  PMID: 25763831 RESULT

• 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.

  PMID: 25848926 RESULT

• 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.

  PMID: 22278105 RESULT

• 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.

  PMID: 22098630 RESULT

• 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.

  PMID: 28583826 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Michael J Bourke, MBBS

CONTACT

+61288905555; endoscopyresearch.westmead@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Model Details: Selective treatment algorithm of ESD or EMR according to risk stratification.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: August 14, 2017
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)