Endoscopic Full-Thickness Resection In Colon

NCT03803891 | Unknown

• 1 other identifier: HU-EMPRET
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 17

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.

Conditions

Colon Neoplasm, Malignant; Colorectal Cancer; Colonic Cancer; Colonic Adenoma; Colorectal Neoplasms; Colorectal Adenocarcinoma; Colon Polyp; Colon Lesion; Colon Neoplasm

Keywords

Endoscopic resection; Colonoscopy; Full-thickness resection

Outcome Measures

Primary Outcomes (1)

• Technical Success

  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 Outcomes (2)

• Major adverse events

  3 months

• Histologically confirmed full-thickness resection

  30 days

Study Arms (1)

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

Interventions

Endoscopic full-thickness resection PROCEDURE

Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions

Endoscopic full-thickness resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (17)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

RECRUITING

Fundació Althaia, Xarxa Assistencial Universitària de Manresa

Manresa, Barcelona, 08243, Spain

RECRUITING

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Hospital de Sant Joan Despí Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

RECRUITING

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, 12002, Spain

RECRUITING

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, La Coruña, 15706, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Quirónsalud Málaga

Málaga, 29004, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 26309354 BACKGROUND

• Uchima 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

• 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.

  PMID: 28798042 BACKGROUND

• Backes 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.

  PMID: 28753696 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Hugo I. Uchima Koecklin, MD

  Medical researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hugo I. Uchima Koecklin, MD

CONTACT

+34 934978866; hugoikuo@gmail.com

Magin Farré Albadalejo

CONTACT

mfarre.germanstrias@gencat.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Specialist (gastroenterologist, MD)

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 15, 2019
• Study Start: May 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: July 31, 2020
• Last Updated: January 15, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17)