NCT04484311

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 20, 2020

Last Update Submit

September 21, 2020

Conditions

Gastric NeoplasmEsophageal NeoplasmsColorectal Neoplasms

Keywords

Endoscopic therapyEndoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

  • Residual neoplasia

    Presence of residual neoplasia after non-curative ESD

    2010-2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients without endoscopic follow-up or surgery will be excluded from the analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital S. João

Porto, Portugal

RECRUITING

Related Publications (2)

  • 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.

    PMID: 37666656DERIVED

  • 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.

    PMID: 35863354DERIVED

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • João Santos-Antunes

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

    PRINCIPAL INVESTIGATOR

  • Guilherme Macedo, MD, PhD

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

    STUDY DIRECTOR

Central Study Contacts

João Santos-Antunes, MD, MSc

CONTACT

+351917490406joao.claudio.antunes@gmail.com

Guilherme Macedo, MD, PhD

CONTACT

guilhermemacedo59@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 23, 2020

Study Start

August 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

September 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)