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

Not yet recruiting

• Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenoma
• Interventions: Other: EMR or ESD

• Registration Number: NCT05653960
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Study Start: 2024-12-01
• Primary Completion: 2033-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• Subjects who undergo EMR or ESD for colorectal lesions.

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Exclusion Criteria

• Not applicable.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects who undergo EMR or ESD	EMR or ESD	Subjects who undergo EMR or ESD for colorectal lesions

Primary Outcome Measures

Name	Time	Method
Curative resection rate of EMR or ESD for colorectal neoplasms	10 years	The short- and long-term clinical efficacy outcomes of colorectal EMR or ESD
Adverse event rate of EMR or ESD for colorectal neoplasms	10 years	The short- and long-term clinical safety outcomes of colorectal EMR or ESD

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong