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Endoscopic Full-Thickness Resection In Colon (EFTRICOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803891
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
Sociedad Española de Endoscopia Digestiva
Hospital de Sant Joan Despí Moisès Broggi
Complejo Hospitalario de Navarra
Hospital Clínico Universitario de Santiago de Compostela
Hospital Provincial de Castellon
Althaia Xarxa Assistencial Universitària de Manresa
Hospital Mutua de Terrassa
Hospital General Universitario Gregorio Marañon
Hospital Clínico San Carlos
Hospital Universitario 12 de Octubre
Hospital General de Ciudad Real
Hospital General Universitario Elche
Hospital Universitario Central de Asturias
Hospital Clinic of Barcelona
Quironsalud
Hospital Universitario La Paz
Centro Medico Teknon
Germans Trias i Pujol Hospital
Information provided by (Responsible Party):
HugoUchima, Fundació Institut Germans Trias i Pujol

Brief Summary:
Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) as a closure mechanism is a recent technique that allows the endoscopic resection of colonic lesions that are poor candidates for conventional endoscopic resection techniques. The aim is to study the safety and efficacy of EFTR in colon.

Condition or disease Intervention/treatment
Colon Neoplasm, Malignant Colo-rectal Cancer Colonic Cancer Colonic Adenoma Colorectal Cancer Colorectal Neoplasms Colorectal Adenocarcinoma Colon Polyp Colon Lesion Colon Neoplasm Procedure: Endoscopic full-thickness resection

Detailed Description:

Early detection and endoscopic resection of early neoplastic lesions in colon can prevent the development of colon cancer.

The classic endoscopic mucosal resection technique and the submucosal dissection technique require the creation of a submucosal "cushion" by injecting crystalloid substances or colloids. However, these advanced techniques have technical limitations when facing a lesion that presents poor lifting or non-lifting at all as it might be observed in scarring or fibrotic lesions

Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) is a recent technique that does not require the injection of a submucosal solution and allows a resection of colonic lesions of up to approximately 30 mm, en bloc, allowing a correct histological study of the sample, to confirm its complete resection with adequate deep margins, evaluation of the level of invasion and lymphovascular involvement.

EFTR with OTSC allows a colonic wall full-thickness resection, by the deployment of an over-the-scope clip before the resection of the lesion to prevent perforation. The steps of the technique are: face the lesion and marking the borders, insertion of the scope with the kit (consisting of a cap with an integrated snare and OTSC), grasping and pulling the lesion into the cap, deploy the over-the-scope-clip (OTSC) and closing the integrated snare and resect.

This is a multicenter observational study on the efficacy and safety of EFTR with OTSC in colon.

The clinical, endoscopic and histological data are collected prospectively in all cases of EFTR performed in the participant centers.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Endoscopic full-thickness resection
Patients with neoplastic lesions less than 30mm unresectable en bloc by other less invasive endoscopic techniques, including lesions suggestive of T1 colorectal cancer, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting sign (recurrent, incomplete prior resection or untreated lesions).
Procedure: Endoscopic full-thickness resection
Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions




Primary Outcome Measures :
  1. Technical Success [ Time Frame: Through study completion, an average of 1 year ]
    Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection


Secondary Outcome Measures :
  1. Major adverse events [ Time Frame: 3 months ]
    Percentage of procedure-associated major adverse events: bleeding and/or perforation

  2. Histologically confirmed full-thickness resection [ Time Frame: 30 days ]
    Histologically confirmed full-thickness resection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who undergo a endoscopic full-thickness resection for colonic lesions who meet the inclusion criteria will be included consecutively.
Criteria

Inclusion Criteria:

  • Adults (≥18 years) of both sexes.
  • Colonic lesions less than 30mm unresectable en-bloc by other less invasive endoscopic techniques, including lesions suggestive of T1, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting signs (recurrent, incomplete prior resection or untreated).
  • Patients who give their written informed consent for the procedure and for the study.

Exclusion Criteria:

  • Refusal to grant informed consent.
  • Neoplastic lesions of the colon with evidence of advanced stage (for example, lymph node involvement) or more than 3 cm in greatest diameter.
  • Any medical, psychological, geographical, or social problem that is significant and uncontrolled that may interfere with the patient's participation in the study or that does not allow adequate follow-up and adherence to the protocol and evaluation of the results of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803891


Contacts
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Contact: Hugo I. Uchima Koecklin, MD +34 934978866 hugoikuo@gmail.com
Contact: Magin Farré Albadalejo mfarre.germanstrias@gencat.cat

Locations
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Spain
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain, 03203
Contact       jsolavera@gmail.com   
Principal Investigator: Javier Sola Vera         
Fundació Althaia, Xarxa Assistencial Universitària de Manresa Recruiting
Manresa, Barcelona, Spain, 08243
Contact       ignasipuig@gmail.com   
Principal Investigator: Ignasi Puig del Castillo         
Hospital de Sant Joan Despí Moisès Broggi Recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Contact       alexfsimon@gmail.com   
Principal Investigator: Alejandro Fernández         
Hospital de Sant Joan Despí Moisès Broggi Recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Contact       alfredomatabil@yahoo.es   
Principal Investigator: Alfredo Mata Bilbao         
Hospital de Sant Joan Despí Moisès Broggi Recruiting
Sant Joan Despí, Barcelona, Spain, 08970
Contact       David.BarqueroDeclara@sanitatintegral.org   
Principal Investigator: David Barquero         
Hospital Universitari Mútua de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Contact       jcespinos@gmail.com   
Principal Investigator: Jorge Carlos Espinós         
Consorcio Hospitalario Provincial de Castellón Recruiting
Castelló de la Plana, Castellón, Spain, 12002
Contact       sabado@uji.es   
Principal Investigator: Fernando Sábado         
Hospital Clínico Universitario de Santiago de Compostela Recruiting
Santiago De Compostela, La Coruña, Spain, 15706
Contact       franmartingastro@yahoo.es   
Principal Investigator: Francisco Martín         
Complejo Hospitalario de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact       edualbeniz@hotmail.com   
Principal Investigator: Eduardo Albéniz         
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact       MPELLISE@clinic.cat   
Principal Investigator: Maria Pellisé         
Hospital General Universitario de Ciudad Real Recruiting
Ciudad Real, Spain, 13005
Contact       joakinrodriguez@gmail.com   
Principal Investigator: Joaquín Rodríguez Sánchez         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact       jgarcialledo@gmail.com   
Principal Investigator: Javier García Lledó         
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact       jestebanl@yahoo.es   
Principal Investigator: José Miguel Esteban         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact       josecarlos.marin@salud.madrid.org   
Principal Investigator: José Carlos Marín Gabriel         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact       pedro.demaria@gmail.com   
Principal Investigator: Pedro De María Pallarés         
Hospital Quirónsalud Málaga Recruiting
Málaga, Spain, 29004
Contact       pjroson@gmail.com   
Principal Investigator: Pedro J. Rosón         
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Contact       miguelfrailelopez@gmail.com   
Principal Investigator: Miguel Fraile López         
Sponsors and Collaborators
Fundació Institut Germans Trias i Pujol
Sociedad Española de Endoscopia Digestiva
Hospital de Sant Joan Despí Moisès Broggi
Complejo Hospitalario de Navarra
Hospital Clínico Universitario de Santiago de Compostela
Hospital Provincial de Castellon
Althaia Xarxa Assistencial Universitària de Manresa
Hospital Mutua de Terrassa
Hospital General Universitario Gregorio Marañon
Hospital Clínico San Carlos
Hospital Universitario 12 de Octubre
Hospital General de Ciudad Real
Hospital General Universitario Elche
Hospital Universitario Central de Asturias
Hospital Clinic of Barcelona
Quironsalud
Hospital Universitario La Paz
Centro Medico Teknon
Germans Trias i Pujol Hospital
Investigators
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Principal Investigator: Hugo I. Uchima Koecklin, MD Medical researcher
Additional Information:

Publications:
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Responsible Party: HugoUchima, Medical Specialist (gastroenterologist, MD), Fundació Institut Germans Trias i Pujol
ClinicalTrials.gov Identifier: NCT03803891    
Other Study ID Numbers: HU-EMPRET
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HugoUchima, Fundació Institut Germans Trias i Pujol:
Endoscopic resection
Colonoscopy
Full-thickness resection
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Adenoma
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type