Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study

Adenoma Clinical Trial

— FiRE  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02353533
• Other study ID #: FiRE
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2015
• Last updated: November 18, 2016
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Technische Universität München
• Contact: Peter Klare, MD
• Phone: +49 89 4140 2251
• Email: peter.klare[@]lrz.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients = 18 years

• adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign")

Exclusion Criteria:

• patients < 18 years

• lesions > 20 mm in size

• high risk carcinomas ("deep submucosal carcinoma")

• American Society of Anesthesiologists (ASA) class IV and higher

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoma

Intervention

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
• EMR
Standard endoscopic mucosal resection using a resection snare

Locations

Country	Name	City	State
Germany	II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of resection	Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment	3 month	No
Secondary	Duration of procedure		up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)	No