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NCT Number: NCT05653960

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

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects who undergo EMR or ESD for colorectal lesions.

Exclusion criteria

  • Not applicable.

Treatment and study plan

EMR or ESD

Other

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

Primary outcomes

  1. Curative resection rate of EMR or ESD for colorectal neoplasms

    Time frame: 10 years

    The short- and long-term clinical efficacy outcomes of colorectal EMR or ESD

  2. Adverse event rate of EMR or ESD for colorectal neoplasms

    Time frame: 10 years

    The short- and long-term clinical safety outcomes of colorectal EMR or ESD

Study contacts

Contact information is provided by the study sponsor or research team.

Louis Lau

CONTACT

[email protected]

6049 0760

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Dec 16, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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