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

NCT ID: NCT05653960

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2033-12-31

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.

Conditions

Colorectal Cancer; Colorectal Neoplasms; Colorectal Adenoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Subjects who undergo EMR or ESD

Subjects who undergo EMR or ESD for colorectal lesions

EMR or ESD

Intervention Type: OTHER

Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms

Interventions

EMR or ESD

Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects who undergo EMR or ESD for colorectal lesions.

Exclusion Criteria

• Not applicable.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Louis Ho Shing Lau

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis Lau

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital

Locations

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Countries

Hong Kong

Central Contacts

Louis Lau

Role: CONTACT

louishslau@cuhk.edu.lhk

6049 0760

Other Identifiers

2022.474

Identifier Type: -

Identifier Source: org_study_id