Endoscopic Full-Thickness Resection In Colon (EFTRICOM)

January 10, 2019 updated by: HugoUchima, Fundació Institut Germans Trias i Pujol

Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
        • Principal Investigator:
          • Maria Pellise
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
        • Contact:
        • Principal Investigator:
          • Joaquín Rodríguez Sánchez
      • Madrid, Spain, 28041
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Pedro De María Pallarés
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
        • Principal Investigator:
          • José Miguel Esteban
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
        • Principal Investigator:
          • Javier García Lledó
      • Málaga, Spain, 29004
        • Recruiting
        • Hospital Quironsalud Malaga
        • Contact:
        • Principal Investigator:
          • Pedro J. Rosón
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Miguel Fraile López
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
        • Contact:
        • Principal Investigator:
          • Javier Sola Vera
    • Barcelona
      • Manresa, Barcelona, Spain, 08243
        • Recruiting
        • Fundació Althaia, Xarxa Assistencial Universitària de Manresa
        • Contact:
        • Principal Investigator:
          • Ignasi Puig del Castillo
      • Sant Joan Despí, Barcelona, Spain, 08970
      • Terrassa, Barcelona, Spain, 08221
        • Recruiting
        • Hospital Universitari Mutua de Terrassa
        • Contact:
        • Principal Investigator:
          • Jorge Carlos Espinós
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12002
        • Recruiting
        • Consorcio Hospitalario Provincial de Castellón
        • Contact:
        • Principal Investigator:
          • Fernando Sábado
    • La Coruña
      • Santiago De Compostela, La Coruña, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago de Compostela
        • Contact:
        • Principal Investigator:
          • Francisco Martín
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Recruiting
        • Complejo Hospitalario de Navarra
        • Contact:
        • Principal Investigator:
          • Eduardo Albéniz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse events
Time Frame: 3 months
Percentage of procedure-associated major adverse events: bleeding and/or perforation
3 months
Histologically confirmed full-thickness resection
Time Frame: 30 days
Histologically confirmed full-thickness resection
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut Germans Trias i Pujol

Collaborators

Hospital General Universitario Gregorio Marañon
Hospital Clinic of Barcelona
Hospital General Universitario Elche
Germans Trias i Pujol Hospital
Complejo Hospitalario de Navarra
Hospital Universitario 12 de Octubre
Hospital Mutua de Terrassa
Althaia Xarxa Assistencial Universitària de Manresa
Centro Medico Teknon
Spanish Society of Digestive Endoscopy
Hospital San Carlos, Madrid
Hospital Universitario La Paz
Hospital de Sant Joan Despí Moisès Broggi
Hospital Clínico Universitario de Santiago de Compostela
Hospital Provincial de Castellon
Hospital General de Ciudad Real
Hospital Universitario Central de Asturias
Quironsalud

Investigators

  • Principal Investigator: Hugo I. Uchima Koecklin, MD, Medical Researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

January 31, 2020

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-EMPRET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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