Status:
UNKNOWN
Endoscopic Full-Thickness Resection In Colon
Lead Sponsor:
Fundació Institut Germans Trias i Pujol
Collaborating Sponsors:
Spanish Society of Digestive Endoscopy
Hospital de Sant Joan Despí Moisès Broggi
Conditions:
Colon Neoplasm, Malignant
Colo-rectal Cancer
Eligibility:
All Genders
18+ years
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 ar...
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 dissec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03803891
Start Date
May 1 2018
End Date
July 31 2020
Last Update
January 15 2019
Active Locations (17)
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1
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
2
Fundació Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, Spain, 08243
3
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain, 08970
4
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, Barcelona, Spain, 08970