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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05653960
• Other study ID #: 2022.474
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 31, 2033

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Louis Lau
• Phone: 6049 0760
• Email: louishslau[@]cuhk.edu.lhk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2033
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects who undergo EMR or ESD for colorectal lesions.

Exclusion Criteria:

• Not applicable.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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