Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study (FiRE)
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|ClinicalTrials.gov Identifier: NCT02353533|
Recruitment Status : Unknown
Verified November 2016 by Dr. Peter Klare, Technische Universität München.
Recruitment status was: Recruiting
First Posted : February 2, 2015
Last Update Posted : November 21, 2016
Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique.
Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas.
In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).
|Condition or disease||Intervention/treatment||Phase|
|Adenoma||Device: over- the- scope full- thickness resection device (FTRD) Device: EMR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||December 2017|
Standard EMR technique
Standard endoscopic mucosal resection using a resection snare
Device: over- the- scope full- thickness resection device (FTRD)
Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device
- Success of resection [ Time Frame: 3 month ]Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment
- Duration of procedure [ Time Frame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353533
|Contact: Peter Klare, MD||+49 89 4140 firstname.lastname@example.org|
|Contact: Stefan von Delius, MD||+49 89 4140 email@example.com|
|II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München||Recruiting|
|Munich, Germany, 81675|
|Contact: Peter Klare, MD +49 89 4140 2251 firstname.lastname@example.org|
|Contact: Stefan von Delius, MD +49 89 4140 5973 email@example.com|
|Principal Investigator: Peter Klare, MD|
|Principal Investigator: Stefan von Delius, MD|
|Study Director:||Stefan von Delius, MD||II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany|