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Not yet recruiting NCT05653960

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

Observational Colorectal Cancer Colorectal Neoplasms Colorectal Adenoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EMR or ESD.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Curative resection rate of EMR or ESD for colorectal neoplasms [Time frame: 10 years]
  • Adverse event rate of EMR or ESD for colorectal neoplasms [Time frame: 10 years]

Eligibility criteria

Inclusion criteria

  • Subjects who undergo EMR or ESD for colorectal lesions.

Exclusion criteria

  • Not applicable.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital — Shatin

Identifiers

NCT: NCT05653960 · 2022.474

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗