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Trial Title:
Clinical Outcomes After EMR or ESD of Colorectal Neoplasms - A Multicenter Registry
NCT ID:
NCT05653960
Condition:
Colorectal Cancer
Colorectal Neoplasms
Colorectal Adenoma
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Adenoma
Conditions: Keywords:
Endoscopic mucosal resection
Endoscopic submucosal dissection
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
EMR or ESD
Description:
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two
main endoscopic treatment options for colorectal neoplasms
Arm group label:
Subjects who undergo EMR or ESD
Summary:
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.
Criteria for eligibility:
Study pop:
Subjects who undergo EMR or ESD for colorectal lesions.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Subjects who undergo EMR or ESD for colorectal lesions.
Exclusion Criteria:
- Not applicable.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Locations:
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Shatin
Country:
Hong Kong
Start date:
December 1, 2024
Completion date:
December 31, 2033
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05653960
