Prevention of colorectal cancer by colonoscopic polypectomy. The National Polyp Study Workgroup.
S J Winawer, A G Zauber, M N Ho...
https://pubmed.ncbi.nlm.nih.gov/8247072Actively Recruiting
Led by Western Sydney Local Health District · Updated on 2025-03-27
391
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Total: 1 location
1
Westmead Endoscopy Unit
Westmead, New South Wales, Australia, 2145
Actively Recruiting
M
Michael J Bourke, MBBS
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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