Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• All patients referred for colorectal resection of large laterally spreading lesions in colon.
• Can give informed consent to trial participation
Locations
Other Locations
Australia
Westmead Endoscopy Unit
RECRUITING
Westmead
Contact Information
Primary
Michael J Bourke, MBBS
endoscopyresearch.westmead@gmail.com
+61288905555
Time Frame
Start Date: 2017-08-14
Estimated Completion Date: 2028-02
Participants
Target number of participants: 391
Treatments
Active_comparator: ESD
Lesion with overt stigmata of SMIC or those with high risk (=\> 10%) for covert SMIC.
Active_comparator: EMR
Lesion with no overt or a low risk for (\<10%) for covert SMIC
Related Therapeutic Areas
Sponsors
Leads: Western Sydney Local Health District