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

August 26, 2024 updated by: Louis Ho Shing Lau, Chinese University of Hong Kong

The Clinical Outcomes After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjects who undergo EMR or ESD for colorectal lesions.

Description

Inclusion Criteria:

  • Subjects who undergo EMR or ESD for colorectal lesions.

Exclusion Criteria:

  • Not applicable.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who undergo EMR or ESD
Subjects who undergo EMR or ESD for colorectal lesions
Other: EMR or ESD
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 years
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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Louis Lau, Prince of Wales Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022.474

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Neoplasms

Clinical Trials on EMR or ESD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe