Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04008407

Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study

Led by Western Sydney Local Health District · Updated on 2025-03-27

391

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a selective strategy using Endoscopic Submucosal Dissection (ESD) for treating large laterally spreading lesions (LSL) of the colorectum, which are at high risk of progressing to cancer. These lesions, especially those 20mm or larger, have a higher chance of malignancy and recurrence after removal. The study focuses on lesions with overt signs of submucosal invasive cancer (SMIC) or those at high risk for covert SMIC, aiming to improve histological staging and potentially reduce the need for surgery. The study compares two procedures: ESD, which allows for en-bloc resection and precise histopathological assessment, and Endoscopic Mucosal Resection (EMR), the current standard treatment that often requires piecemeal resection. Patients with lesions showing overt or high risk (≥10%) of covert SMIC are selected for ESD, while others with low-risk lesions may receive EMR. The research team will follow a prospective cohort design to assess this selective approach in the Western population. Participants will be monitored for outcomes including surgical referral rates at three months post-procedure, resection success rates, procedure duration, and adenoma recurrence rates over three years. The study involves detailed assessments of lesion removal quality and patient follow-up to evaluate the safety and effectiveness of the selective ESD strategy compared to EMR. Participation includes consenting adults referred for colorectal lesion resection and undergoing the assigned treatment with ongoing evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred for removal of large laterally spreading colorectal lesions
  • Able to provide informed consent to participate in the trial
Not Eligible

You will not qualify if you...

  • Previous resection or attempted removal of the target adenoma lesion
  • Visible signs of invasive cancer during endoscopy
  • Under 18 years of age
  • Pregnancy
  • Active inflammatory bowel conditions (e.g., inflammatory bowel disease)
  • Use of blood-thinning medications outside of accepted guidelines (except aspirin)
  • American Society of Anesthesiology (ASA) Grade IV or V status indicating severe health risks

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Procedure day with follow-up up to 3 months

Participants undergo either Endoscopic Submucosal Dissection (ESD) or Endoscopic Mucosal Resection (EMR) to remove large laterally spreading colorectal lesions based on their risk of submucosal invasive cancer (SMIC).

1 procedure visit and approximately 1 to 2 post-procedure visits over 3 months

Follow-up

Duration - Up to 3 years post procedure

Participants are monitored for adenoma recurrence and surgical referrals after the treatment.

Periodic visits for follow-up assessments up to 3 years

Trial Site Locations

Total: 1 location

1

Westmead Endoscopy Unit

Westmead, New South Wales, Australia, 2145

Actively Recruiting

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Research Team

M

Michael J Bourke, MBBS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia.

Alan Moss, Michael J Bourke, Stephen J Williams...

https://pubmed.ncbi.nlm.nih.gov/21392504

Endoscopic mucosal resection of laterally spreading lesions involving the ileocecal valve: technique, risk factors for failure, and outcomes.

Kavinderjit S Nanda, Nicholas Tutticci, Nicholas G Burgess...

https://pubmed.ncbi.nlm.nih.gov/25763831

Endoscopic treatment of large colorectal tumors: comparison of endoscopic mucosal resection, endoscopic mucosal resection-precutting, and endoscopic submucosal dissection.

Eun-Jung Lee, Jae Bum Lee, Suk Hee Lee...

https://pubmed.ncbi.nlm.nih.gov/22278105

Clinical outcomes of endoscopic submucosal dissection and endoscopic mucosal resection for laterally spreading tumors larger than 20 mm.

Motomi Terasaki, Shinji Tanaka, Shiro Oka...

https://pubmed.ncbi.nlm.nih.gov/22098630

Risk Stratification for Covert Invasive Cancer Among Patients Referred for Colonic Endoscopic Mucosal Resection: A Large Multicenter Cohort.

Nicholas G Burgess, Luke F Hourigan, Simon A Zanati...

https://pubmed.ncbi.nlm.nih.gov/28583826