Share
Save
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
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.
Study details:
With over 14,000 patients diagnosed annually, colorectal carcinoma (CRC) is the second most frequently invasive malignancy in Australia. By not only diagnosing CRC at an early stage, but also removing precursor adenomas, colonoscopy with polypectomy reduces the risk of developing and dying from CRC. Laterally spreading lesions \>= 20mm (LSL) are more likely to progress to cancer.
The prevalence of LSL ranges from 1-5% in screening population. The risk of malignant progression of colorectal adenomas found during colonoscopy increases with lesion size, i. e.
the cancer preventive effect is likely to be maximal in large lesions. Patients with LSL have a higher risk of malignancy and a higher recurrence rate of adenoma after lesion removal compared with diminutive polyps. Endoscopic imaging can now accurately predict LSL with submucosal invasive cancer (SMIC) through assessment of LSLs morphology (Paris classification, granularity) and surface pit-pattern (Kudo classification).
Such cases can be considered to have LSL with overt risk of SMIC. Recent publication has highlighted that some LSLs might hrbor SMIC without overt morphological features (i. e.
high risk for covert SMIC). These LSL with high risk of covert SMIC stratified LSLs based on lesion location and lesion morphology. Generally LSLs can be safely and effectively removed by wide field endoscopic mucosal resection (WF-EMR) in over 90% of cases in competent hands.
One of the draw backs with WF-EMR is it requires piecemeal resection and thus is limited in providing assessment of complete excision and depth of submucosal invasion in cases where SMIC is present. Thus, endoscopic en-bloc resection is preferable from an oncologic standpoint to obtain a single specimen for proper histopathologic assessment. Endoscopic submucosal dissection (ESD) is a technique that is now becoming the preferred method for achieving a complete endoscopic and histologic resection, referred to as R0.
Evidence from retrospective cohort and meta-analyses suggests ESD provides a more consistent oncologic resection with a reduced rate of recurrence. However, the major limitations with the technique relate to increased procedure time and the skill-set required for performing the procedure. One of the other major limitations of ESD is significant cost associated with the procedure, which includes procedure time and additional equipment in addition to the treatment of any subsequent complications.
As such the implementation of ESD as the standard of care for all colorectal lesions has not been undertaken in Western countries, however it may have an important role for selective cases especially where there is concern for sub-mucosal invasive cancer (SMIC). The investigators propose a selective ESD strategy to be performed for patients focusing on overt evidence of SMIC and those at high risk of covert SMIC (defined as risk \>10%). The investigators will follow a prospective cohort study assessing the use of selective ESD strategy in the colorectum in the Western population.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2017-08-14
Primary completion: 2027-08-01
Study completion finish: 2028-02-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT04008407
Intervention or treatment
PROCEDURE: Endoscopic Submucosal Dissection
PROCEDURE: Endoscopic Mucosal Resection
Conditions
- • Colorectal Neoplasm
- • Endoscopic Mucosal Resection
Find a site
Closest Location:
Westmead Endoscopy Unit
Research sites nearby
Select from list below to view details:
Westmead Endoscopy Unit
Westmead, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
ACTIVE_COMPARATOR: ESD
| PROCEDURE: Endoscopic Submucosal Dissection
|
ACTIVE_COMPARATOR: EMR
| PROCEDURE: Endoscopic Mucosal Resection
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Rate of surgical referral | Incidence of surgical referral due to non-curative endoscopic resection. | 3 months post procedure |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
R0 resection rate | Rate of en-bloc resection with clear resection margins. | 3 months post procedure |
En Bloc resection rate | Rate of en-bloc resection | 3 months post procedure |
Technical success rate | Rate of procedures completed as per protocol | 3 months post procedure |
Duration of procedure | Procedure duration in minutes. | procedure |
Adenoma recurrence rate | Rate of recurrent adenoma at resection site on follow-up. | 3 years post procedure |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!