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Prospective Registration of endoscopic Full Thickness Resection in the Netherlands


- candidate number26955
- NTR NumberNTR6292
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR26-mrt-2017
- Secondary IDsW16_262#16.308 METC AMC
- Public TitleProspective Registration of endoscopic Full Thickness Resection in the Netherlands
- Scientific TitleProspective Registration of endoscopic Full Thickness Resection in the Netherlands
- ACRONYM
- hypothesisWe aim to study the applicability, safety and technical success of all scheduled eFTR procedures in the Netherlands.
- Healt Condition(s) or Problem(s) studiedColorectal lesions, Colonoscopy
- Inclusion criteriaWe will prospectively include all patients who are scheduled to undergo an eFTR procedure with the FTRD performed by one of the trained endoscopists in the Netherlands.
In order to be eligible to be included in this study a patient must meet all of the following criteria:
- Scheduled to undergo eFTR procedure with the FTRD performed by one of the trained endoscopists in performing FTRD procedures in the Netherlands
- Exclusion criteriaThere are no formal exclusion criteria since the indication for a full thickness resection of all patients was already set by a trained endoscopist in the Netherlands.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2017
- planned closingdate1-jan-2019
- Target number of participants200
- InterventionsThere will be no formal interventions in this study, since this is a prospective registration of endoscopic full-thickness resection, wherefore the indication for this procedure is already set by an trained endoscopist.
- Primary outcomeOur main study endpoint is the technical success rate of all scheduled eFTR procedures with the FTRD defined as the number of patients with a complete endoscopic en bloc resection in the Netherlands.
- Secondary outcomeThe following secondary study parameters are designed to further study the technical success, the applicability and the safety of all eFTR procedures in the Netherlands;
- The number of patients with histologically confirmed R0 resection defined as negative lateral and deep margins
- The number of patients with a histologically confirmed full thickness resection
- The number of eFTR procedures in which the procedure was not technical succesfull, due to the inability to reach the lesion, the inability to retract all the tissue in the FTRD and technical difficulties with the FTRD
- Number of intra procedural complications, defined as any perforation or a bleeding for which an additional intervention, defined as transfusion, admission, radiologic intervention or surgical treatment is required
- Number of patients with early (48 hours) and late (until 14 days) postprocedural complications for which additional treatment is necessary, defined as presentation at the emergency ward, transfusion, admission, repeat endoscopy, radiologic intervention or surgical treatment
- The occurrence of recurrence during follow-up colonoscopies
- Procedural time
- Timepoints01-06-2017: evaluation of 6 months inclusion period
01-01-2018: evaluation of a one year inclusion period
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD Candidate Maxime E.S. Bronzwaer
- CONTACT for SCIENTIFIC QUERIESDr. P. Fockens
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryMost benign colorectal polyps can be endoscopically removed with conventional polypectomy techniques, including piecemeal endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). However, these techniques are limited to the superficial layers of the colonic wall and although sufficient in the majority of cases, a subset of lesions cannot be treated conventionally. These difficult to remove colorectal polyps consist of large (≥40 mm) flat lesions, non-lifting lesions, or lesions located at difficult anatomic locations involving the ileocecal valve, a diverticulum or the appendiceal orifice.

In order to overcome some of the technical challenges of the endoscopic removal of complex lesions a novel endoscopic device has been developed to perform endoscopic full-thickness resection (eFTR) with immediate secure defect closure. This full-thickness resection device (FTRD, Ovesco Endoscopy, Tübingen, Germany) consists of a modified over-the-scope clip (OTSC) mounted on a cap with a preloaded snare. It has been investigated in preclinical trials and a recent clinical case series of 25 colorectal lesions. However more clinical research is needed to further investigate the clinical applicability, technical success rates and safety of performing eFTR with the FTRD. Therefore we will perform a prospective registration of all scheduled eFTR procedures with the FTRD in the Netherlands to further investigate the applicability, technical success rates and safety of this device. The technical success of all scheduled eFTR procedures in the Netherlands is defined as the number of endoscopic complete en bloc resections and the number of histologically confirmed R0 and full-thickness resection. The applicability and safety of all scheduled eFTR procedures will studied when investigating the number of scheduled eFTR procedues that were note completely performed, procedural time, complication rates and the occurrence of local recurrence during surveillance colonoscopies.
- Main changes (audit trail)
- RECORD26-mrt-2017 - 14-mei-2017


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