RecruitingNot ApplicableNCT04008407

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

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

Sponsor

Western Sydney Local Health District

Enrollment

391 participants

Start Date

Aug 14, 2017

Study Type

INTERVENTIONAL

Conditions

Colorectal Neoplasm Endoscopic Mucosal Resection

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a specialized endoscopic technique called ESD (endoscopic submucosal dissection) for removing large, flat colorectal lesions — called laterally spreading lesions — without surgery. The goal is to understand which of these lesions can safely be removed this way and which need a different approach. **You may be eligible if...** - You have been referred for removal of a large, flat colorectal lesion (laterally spreading lesion) - You are able to give informed consent to participate **You may NOT be eligible if...** - You are unable to provide informed consent - Your lesion is not appropriate for endoscopic removal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic 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).

PROCEDUREEndoscopic 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.