ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern Sydney Local Health District
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
All patients referred for colorectal resection of large laterally spreading lesions in colon.
Can give informed consent to trial participation
Disqualifiers
Previous resection or attempted resection of target adenoma lesion
Endoscopic appearance of invasive malignancy
Age less than 18 years
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Endoscopic Submucosal Dissection
Procedure/SurgeryEndoscopic 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).
Endoscopic Mucosal Resection
Procedure/SurgeryEMR 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.
Treatment groups
391 Participants
are divided into 2 treatment groupsGroup A: ESDActive comparator 1 intervention
Group B: EMRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of surgical referral
Incidence of surgical referral due to non-curative endoscopic resection.
Time frame
3 months post procedureSecondary outcomes
1
R0 resection rate
Rate of en-bloc resection with clear resection margins.
Time frame
3 months post procedure2
En Bloc resection rate
Rate of en-bloc resection
Time frame
3 months post procedure3
Technical success rate
Rate of procedures completed as per protocol
Time frame
3 months post procedure4
Duration of procedure
Procedure duration in minutes.
Time frame
procedureSponsors and contacts
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Source ClinicalTrials.gov