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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05653960
Collaborator
(none)
2,500
1
132
18.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: EMR or 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
The Clinical Outcomes After Endoscopic Mucosal Resection or Endoscopic Submucosal Dissection of Colorectal Neoplasms - A Multicenter Registry
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2033
Anticipated Study Completion Date :
Dec 31, 2033

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Curative resection rate of EMR or ESD for colorectal neoplasms [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 [10 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Subjects who undergo EMR or ESD for colorectal lesions.
Exclusion Criteria:
  • Not applicable.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prince of Wales Hospital Shatin New Territories Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Louis Lau, Prince of Wales Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Louis Ho Shing Lau, Clinical Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05653960
Other Study ID Numbers:
  • 2022.474
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Louis Ho Shing Lau, Clinical Assistant Professor, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2022