Colon Neoplasm, MalignantEFTRICOMNCT03803891
Endoscopic Full-Thickness Resection In Colon
An observational study of Colon Neoplasm, Malignant and Colo-rectal Cancer, run by Fundació Institut Germans Trias i Pujol at 17 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Neoplasm, Malignant, Colo-rectal Cancer, Colonic Cancer
- What is being tested?
- Endoscopic full-thickness resection
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 17 sitesSpain
- Study dates
- 1 May 2018to 31 Jul 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who undergo a endoscopic full-thickness resection for colonic lesions who meet the inclusion criteria will be included consecutively.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 1 country.
Magin Farré Albadalejo contact
17 sites in 1 country
Spain17 sites, 17 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
MPELLISE@clinic.cat
Maria Pellisé
- Recruiting
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón, 12002
sabado@uji.es
Fernando Sábado
- Recruiting
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
joakinrodriguez@gmail.com
Joaquín Rodríguez Sánchez
- Recruiting
Hospital General Universitario de Elche
Elche, Alicante, 03203
jsolavera@gmail.com
Javier Sola Vera
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
jgarcialledo@gmail.com
Javier García Lledó
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
jestebanl@yahoo.es
José Miguel Esteban
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
josecarlos.marin@salud.madrid.org
José Carlos Marín Gabriel
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
pedro.demaria@gmail.com
Pedro De María Pallarés
- Recruiting
Hospital Quirónsalud Málaga
Málaga, 29004
pjroson@gmail.com
Pedro J. Rosón
- Recruiting
Fundació Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
ignasipuig@gmail.com
Ignasi Puig del Castillo
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
miguelfrailelopez@gmail.com
Miguel Fraile López
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
edualbeniz@hotmail.com
Eduardo Albéniz
- Recruiting
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970
alexfsimon@gmail.com
Alejandro Fernández
- Recruiting
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970
alfredomatabil@yahoo.es
Alfredo Mata Bilbao
- Recruiting
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, 08970
David.BarqueroDeclara@sanitatintegral.org
David Barquero
- Recruiting
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, La Coruña, 15706
franmartingastro@yahoo.es
Francisco Martín
- Recruiting
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, 08221
jcespinos@gmail.com
Jorge Carlos Espinós
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Neoplasm, Malignant, Colo-rectal Cancer, Colonic Cancer, Colonic Adenoma, Colorectal Cancer, Colorectal Neoplasms
- Being tested
- Endoscopic full-thickness resection
- Keywords
- Endoscopic resection, Colonoscopy, Full-thickness resection
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic full-thickness resectionProcedure or surgery
Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Endoscopic full-thickness resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Major adverse events
Percentage of procedure-associated major adverse events: bleeding and/or perforation
Measured: 3 months
Histologically confirmed full-thickness resection
Histologically confirmed full-thickness resection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 May 2018
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon Neoplasm, MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy, Hospital de Sant Joan Despí Moisès Broggi, Complejo Hospitalario de Navarra, Hospital Clinico Universitario de Santiago, Hospital Provincial de Castellon, Althaia Xarxa Assistencial Universitària de Manresa, Hospital Mutua de Terrassa, Hospital General Universitario Gregorio Marañon, Hospital San Carlos, Madrid, 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
- Responsible party
- Principal investigator, HugoUchima, Fundació Institut Germans Trias i Pujol
- Investigators
- Hugo I. Uchima Koecklin, MD, Principal investigator, Medical researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803891
- Sponsor's protocol ID
- HU-EMPRET
- Acronym
- EFTRICOM
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt A, Meier B, Caca K. Endoscopic full-thickness resection: Current status. World J Gastroenterol. 2015 Aug 21;21(31):9273-85. doi: 10.3748/wjg.v21.i31.9273.
PubMed 26309354Uchima H, Barquero D, Fernandez A, Mata A, Huertas C, Figa M, Hombrados M, Espinos JC. Su1638 Early Discharge After Endoscopic Full-Thickness Resection in the Colorectum. Gastrointest Endosc. 2017;85:5, AB375
Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.
PubMed 28798042Backes Y, Kappelle WFW, Berk L, Koch AD, Groen JN, de Vos Tot Nederveen Cappel WH, Schwartz MP, Kerkhof M, Siersema PD, Schroder R, Tan TG, Lacle MM, Vleggaar FP, Moons LMG; T1 CRC Working Group. Colorectal endoscopic full-thickness resection using a novel, flat-base over-the-scope clip: a prospective study. Endoscopy. 2017 Nov;49(11):1092-1097. doi: 10.1055/s-0043-114730. Epub 2017 Jul 28.
PubMed 28753696
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)
- ClinicalTrials.gov ID
- NCT03803891
- Acronym / sponsor ID
- EFTRICOM / HU-EMPRET
- Conditions
- Colon Neoplasm, Malignant, Colo-rectal Cancer, Colonic Cancer, Colonic Adenoma, Colorectal Cancer, Colorectal Neoplasms
- Keywords
- Endoscopic resection, Colonoscopy, Full-thickness resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy, Hospital de Sant Joan Despí Moisès Broggi, Complejo Hospitalario de Navarra, Hospital Clinico Universitario de Santiago, Hospital Provincial de Castellon, Althaia Xarxa Assistencial Universitària de Manresa, Hospital Mutua de Terrassa, Hospital General Universitario Gregorio Marañon, Hospital San Carlos, Madrid, 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
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic full-thickness resection | – | Procedure: Endoscopic full-thickness resectionPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who undergo a endoscopic full-thickness resection for colonic lesions who meet the inclusion criteria will be included consecutively.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic full-thickness resectionEndoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions | Procedure or surgery | Endoscopic full-thickness resection |
Primary outcome
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
2 secondary outcomes
Major adverse events
Time frame: 3 months
Histologically confirmed full-thickness resection
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Background: PubMed 26309354Schmidt A, Meier B, Caca K. Endoscopic full-thickness resection: Current status. World J Gastroenterol. 2015 Aug 21;21(31):9273-85. doi: 10.3748/wjg.v21.i31.9273.
- BackgroundUchima H, Barquero D, Fernandez A, Mata A, Huertas C, Figa M, Hombrados M, Espinos JC. Su1638 Early Discharge After Endoscopic Full-Thickness Resection in the Colorectum. Gastrointest Endosc. 2017;85:5, AB375
- Background: PubMed 28798042Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.
- Background: PubMed 28753696Backes Y, Kappelle WFW, Berk L, Koch AD, Groen JN, de Vos Tot Nederveen Cappel WH, Schwartz MP, Kerkhof M, Siersema PD, Schroder R, Tan TG, Lacle MM, Vleggaar FP, Moons LMG; T1 CRC Working Group. Colorectal endoscopic full-thickness resection using a novel, flat-base over-the-scope clip: a prospective study. Endoscopy. 2017 Nov;49(11):1092-1097. doi: 10.1055/s-0043-114730. Epub 2017 Jul 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magin Farré Albadalejo contact
Hugo I. Uchima Koecklin, MD principal investigator
Medical researcher
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Neoplasm, Malignant and Colo-rectal Cancer, run by Fundació Institut Germans Trias i Pujol at 17 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugo I. Uchima Koecklin, MD (+34 934978866, hugoikuo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03803891, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.