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

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

Inclusion Criteria2

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

Exclusion Criteria7

  • 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

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.


Locations(1)

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

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NCT04008407


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