Non-curative ESDs: Assessing the Rates and Risk Factors for Residual Neoplasia

NCT ID: NCT04484311

Last Updated: 2020-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-12-31

Brief Summary

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Short and long outcomes of ESD are well described, particularly in Eastern series. However, the outcome of non-curative ESDs is scarcely reported in the west (particularly among non-gastric or submucosal lesions). Therefore, the aim of this project is to describe the European experience with non-curative ESDs, analysing all the consecutive ESDs performed in several reference centers, assessing the presence of residual lesion in the endoscopic follow-up or in the surgical specimen.

Detailed Description

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Conditions

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Gastric Neoplasm Esophageal Neoplasms Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All patients submitted to ESD due to neoplastic lesions of the gastrointestinal tract

Exclusion Criteria

* Patients without endoscopic follow-up or surgery will be excluded from the analysis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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João Santos-Antunes

Role: PRINCIPAL_INVESTIGATOR

Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal

Guilherme Macedo, MD, PhD

Role: STUDY_DIRECTOR

Gastrointestinal Department, Centro Hospitalar S. João, Porto, Portugal

Locations

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Hospital S. João

Porto, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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João Santos-Antunes, MD, MSc

Role: CONTACT

+351917490406

Guilherme Macedo, MD, PhD

Role: CONTACT

Facility Contacts

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João Antunes

Role: primary

References

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Morais R, Libanio D, Dinis Ribeiro M, Ferreira A, Barreiro P, Bourke MJ, Gupta S, Amaro P, Kuttner Magalhaes R, Cecinato P, Boal Carvalho P, Pinho R, Rodriguez de Santiago E, Sferrazza S, Lemmers A, Figueiredo M, Pioche M, Gallego F, Albeniz E, Ramos Zabala F, Uchima H, Berr F, Wagner A, Marques M, Pimentel-Nunes P, Goncalves M, Mascarenhas A, Soares EG, Xavier S, Faria-Ramos I, Sousa-Pinto B, Gullo I, Carneiro F, Macedo G, Santos-Antunes J. Predicting residual neoplasia after a non-curative gastric ESD: validation and modification of the eCura system in the Western setting: the W-eCura score. Gut. 2023 Dec 7;73(1):105-117. doi: 10.1136/gutjnl-2023-330804.

Reference Type DERIVED
PMID: 37666656 (View on PubMed)

Santos-Antunes J, Pioche M, Ramos-Zabala F, Cecinato P, Gallego Rojo FJ, Barreiro P, Felix C, Sferrazza S, Berr F, Wagner A, Lemmers A, Figueiredo Ferreira M, Albeniz E, Uchima H, Kuttner-Magalhaes R, Fernandes C, Morais R, Gupta S, Martinho-Dias D, Rios E, Faria-Ramos I, Marques M, Bourke MJ, Macedo G. Risk of residual neoplasia after a noncurative colorectal endoscopic submucosal dissection for malignant lesions: a multinational study. Endoscopy. 2023 Mar;55(3):235-244. doi: 10.1055/a-1906-8000. Epub 2022 Jul 21.

Reference Type DERIVED
PMID: 35863354 (View on PubMed)

Other Identifiers

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Non-Curative ESDs Registry

Identifier Type: -

Identifier Source: org_study_id

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