Efficacy and Safety of Endoscopic Resection
1 other identifier
observational
3,000
1 country
1
Brief Summary
An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
April 25, 2013
CompletedFirst Submitted
Initial submission to the registry
February 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 10, 2017
February 1, 2017
9.7 years
February 3, 2017
February 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of complete resections without recurrence
6 month post-endoscopic resection
Eligibility Criteria
Patients with a clinical indication for endoscopic resection at the different participating centers will be consecutively included in this study.
You may qualify if:
- Female and male patients who are at least 18 years old.
- Clinical indication for endoscopic exam and endoscopic resection
- Patients must freely accept their involvement in this study. They shall give a written informed consent
You may not qualify if:
- Patients who do not desire to be included in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EDUARDO ALBENIZlead
- Fundacion Miguel Servetcollaborator
Study Sites (1)
Eduardo Albeniz Arbizu
Pamplona, Navarre, 31008, Spain
Related Publications (1)
Albeniz E, Gimeno-Garcia AZ, Fraile M, Ibanez B, Guarner-Argente C, Alonso-Aguirre P, Alvarez MA, Gargallo CJ, Pellise M, Ramos Zabala F, Herreros de Tejada A, Nogales O, Martinez-Ares D, Mugica F, de la Pena J, Espinos J, Huerta A, Alvarez A, Gonzalez-Santiago JM, Navajas F, Martinez-Cara JG, Redondo-Cerezo E, Merlo Mas J, Sabado F, Rivero L, Saperas E, Soto S, Rodriguez-Sanchez J, Lopez-Roses L, Rodriguez-Tellez M, Rullan Iriarte M, Elosua Gonzalez A, Pardeiro R, Valdivielso Cortazar E, Concepcion-Martin M, Huelin Alvarez P, Colan Hernandez J, Cobian J, Santiago J, Jimenez A, Remedios D, Lopez-Viedma B, Garcia O, Martinez-Alcala F, Perez-Roldan F, Carbo J, Enguita M. Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions. Gastrointest Endosc. 2020 Apr;91(4):868-878.e3. doi: 10.1016/j.gie.2019.10.013. Epub 2019 Oct 23.
PMID: 31655045DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 3, 2017
First Posted
February 10, 2017
Study Start
April 25, 2013
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
February 10, 2017
Record last verified: 2017-02