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| Name | Class |
|---|---|
| Spanish Society of Digestive Endoscopy | OTHER |
| Hospital de Sant Joan Despí Moisès Broggi | OTHER |
| Complejo Hospitalario de Navarra | OTHER |
| Hospital Clínico Universitario de Santiago de Compostela |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic full-thickness resection | Procedure | Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse events | Percentage of procedure-associated major adverse events: bleeding and/or perforation | 3 months |
| Histologically confirmed full-thickness resection | Histologically confirmed full-thickness resection |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who undergo a endoscopic full-thickness resection for colonic lesions who meet the inclusion criteria will be included consecutively.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugo I. Uchima Koecklin, MD | Contact | +34 934978866 | hugoikuo@gmail.com | |
| Magin Farré Albadalejo | Contact | mfarre.germanstrias@gencat.cat |
| Name | Affiliation | Role |
|---|---|---|
| Hugo I. Uchima Koecklin, MD | Medical researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Recruiting | Elche | Alicante | 03203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26309354 | Background | 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. | |
| 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 | ||
| 28798042 |
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| UNKNOWN |
| Hospital Provincial de Castellon | OTHER |
| Althaia Xarxa Assistencial Universitària de Manresa | OTHER |
| Hospital Mutua de Terrassa | OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital San Carlos, Madrid | OTHER |
| Hospital Universitario 12 de Octubre | OTHER |
| Hospital General de Ciudad Real | OTHER |
| Hospital General Universitario Elche | OTHER |
| Hospital Universitario Central de Asturias | OTHER |
| Hospital Clinic of Barcelona | OTHER |
| Quironsalud | OTHER |
| Hospital Universitario La Paz | OTHER |
| Centro Medico Teknon | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
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| 30 days |
| Fundació Althaia, Xarxa Assistencial Universitària de Manresa | Recruiting | Manresa | Barcelona | 08243 | Spain |
|
| Hospital de Sant Joan Despí Moisès Broggi | Recruiting | Sant Joan Despí | Barcelona | 08970 | Spain |
|
| Hospital de Sant Joan Despí Moisès Broggi | Recruiting | Sant Joan Despí | Barcelona | 08970 | Spain |
|
| Hospital de Sant Joan Despí Moisès Broggi | Recruiting | Sant Joan Despí | Barcelona | 08970 | Spain |
|
| Hospital Universitari Mútua de Terrassa | Recruiting | Terrassa | Barcelona | 08221 | Spain |
|
| Consorcio Hospitalario Provincial de Castellón | Recruiting | Castellon | Castellón | 12002 | Spain |
|
| Hospital Clínico Universitario de Santiago de Compostela | Recruiting | Santiago de Compostela | La Coruña | 15706 | Spain |
|
| Complejo Hospitalario de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
|
| Hospital Clínic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
|
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
|
| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | 28007 | Spain |
|
| Hospital Clínico San Carlos | Recruiting | Madrid | 28040 | Spain |
|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
|
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
|
| Hospital Quirónsalud Málaga | Recruiting | Málaga | 29004 | Spain |
|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
|
| 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. |
| 28753696 | 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. |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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