Share

Save

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

RECRUITING

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.

info
Simpliy with AI

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.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

  • 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
  • info
    Simplify with AI

    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

    Study type

    TREATMENT

    phase

    Phase

      NA

    trial

    Trial ID

    NCT04008407

    Intervention or treatment

    PROCEDURE: Endoscopic Submucosal Dissection

    PROCEDURE: Endoscopic Mucosal Resection

    Conditions

    • Colorectal Neoplasm
    • Endoscopic Mucosal Resection
    Image related to Colorectal Neoplasm
    • Condition: Colorectal Neoplasm, Endoscopic Mucosal Resection

    • PROCEDURE: Endoscopic Submucosal Dissection and other drugs

    • Westmead, New South Wales, Australia

    • Sponsor: Western Sydney Local Health District

    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

    Loading...

    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/ArmIntervention/Treatment
    ACTIVE_COMPARATOR: ESD
    • Lesion with overt stigmata of SMIC or those with high risk (=\> 10%) for covert SMIC.
    PROCEDURE: Endoscopic 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).
    ACTIVE_COMPARATOR: EMR
    • Lesion with no overt or a low risk for (\<10%) for covert SMIC
    PROCEDURE: Endoscopic 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.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Rate of surgical referralIncidence of surgical referral due to non-curative endoscopic resection.3 months post procedure

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    R0 resection rateRate of en-bloc resection with clear resection margins.3 months post procedure
    En Bloc resection rateRate of en-bloc resection3 months post procedure
    Technical success rateRate of procedures completed as per protocol3 months post procedure
    Duration of procedureProcedure duration in minutes.procedure
    Adenoma recurrence rateRate 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!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

    Clinical Trials Gov: ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study

    Other trails to consider

    Top searched conditions