Clinical Outcomes After EMR or ESD of Colorectal Neoplasms - A Multicenter Registry

Study Overview
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Brief Summary
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This study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

Detailed Description
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Colorectal cancer (CRC) is one of the most common causes of cancer-related death, however its morbidity and mortality can be reduced by colonoscopy screening and endoscopic removal of adenomas or early cancers.[1] Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms. Despite being a safe and convenient procedure, insufficient resection by EMR can result in a high risk of local recurrence, particularly in lesions ≥ 20 mm. Compared with EMR, ESD facilitates a higher rate of en bloc resection and a lower rate of local recurrence. A recent meta-analysis revealed that the local recurrence rate after colorectal ESD was 1% during a 2-year follow-up period. In addition, ESD can facilitate precise pathological diagnosis to assess the risk of lymph node metastasis of early CRC to judge whether salvage surgery is needed. Although the efficacy of colorectal ESD has been demonstrated, its usage is largely limited by its technical difficulty and risk of complications. Both short- and long-term data on clinical outcomes and safety profiles for colorectal EMR and ESD are needed. Therefore, this study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

Official Title
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The Clinical Outcomes After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Colorectal Neoplasms - A Multicenter Registry

Conditions
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Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma

Intervention / Treatment
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* Other: EMR or ESD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who undergo EMR or ESD for colorectal lesions. Exclusion Criteria: Not applicable.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects who undergo EMR or ESD<br>Subjects who undergo EMR or ESD for colorectal lesions | Other: EMR or ESD<br>* Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Curative resection rate of EMR or ESD for colorectal neoplasms | The short- and long-term clinical efficacy outcomes of colorectal EMR or ESD | 10 years | 
| Adverse event rate of EMR or ESD for colorectal neoplasms | The short- and long-term clinical safety outcomes of colorectal EMR or ESD | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic mucosal resection, Endoscopic submucosal dissection