PreCap-study

Rationale: Endoscopic resection (ER) is the core modality in endoscopic therapy for early esophageal neoplastic lesions (i.e. high grade dysplasia [HGD] or early carcinoma) in Barrett’s esophagus (BE). Histopathological assessment of the resection specimen provides the opportunity to select patients suitable for further endoscopic treatment with additional ER or ablative therapy. Recently, a new MultiBand Mucosectomy (MBM) device (CaptivatorTM EMR, Boston Scientific Corporation, Natick, MA, USA) has been developed which may have advantages over the current MBM device (DuetteTM, Cook Medical, Limerick, Ireland) by improved visualization, passage of accessories, and suction power due to different trigger cords and cap.
Objective: The aim of this study is to assess the safety and efficacy of the new CaptivatorTM EMR device.

Study design: This study will be executed in two phases. Phase I of this study is a prospective randomized trial comparing the CaptivatorTM EMR and the DuetteTM MBM device for which 3-6 patients will be included; phase II is a prospective pilot series with the CaptivatorTM EMR for which 5 patients will be included.

Study population: For phase I adult male and female patients scheduled for esophagectomy will be included. For phase II adult male and female BE patients with known early esophageal neoplastic lesions scheduled for endoscopic resection will be included.

Intervention (if applicable): In phase I, ERs with the CaptivatorTM and DuetteTM device will be performed directly pre-esophagectomy in the upper healthy part of the esophagus. In phase II, all ERs will be performed with the CaptivatorTM EMR device instead of the DuetteTM device.

Main study endpoints: For phase I the primary outcome is the maximum diameter of the resection specimens retrieved with the CaptivatorTM EMR- and DuetteTM devices. For phase II the primary outcome is the percentage of successful endoscopic resections (i.e. resection of all lesion delineation markings).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In phase I, the additional risk with participation is related to the longer sedation time. Patients will not be exposed to significant device associated complications because all the study patients will directly undergo an esophagectomy after the ER procedure. In phase II, patients will undergo a MBM procedure. Since the new CaptivatorTM EMR device is very similar to the current DuetteTM device, no additional risks for the MBM procedure are expected.

Endoscopic resection of Barrett's neoplasia with the Captivator EMR device is effective and safe

Phase I

Time 0: studyendoscopy prior to esophagectomy. After completion of studyendoscopy: end of study



Phase II

Time 0: treatment endoscopy

Time 2 (after 48 hours): telephone call

Phase I:

Endoscopic resection with Captivator EMR device and with Duette EMR device (currently used EMR device) of esophageal tissue prior to esophagectomy



Phase II:

Endoscopic resection of Barrett's neoplasia with Captivator EMR device