Initial Multicenter Experience of Traction Wire Endoscopic Submucosal Dissection

Abstract

Background and Aims

Endoscopic submucosal dissection (ESD) is a technically challenging and time-consuming procedure. A major limitation of ESD is the lack of a “second hand” to provide traction. We have developed a novel retraction device, a traction wire (TW), for ESD. This study was conducted to assess the efficacy, safety, and efficiency of TW-ESD.

Methods

We initially evaluated TW-ESD in a randomized live pig study. After the device was approved for clinical use, we used it in patients undergoing ESD at 8 academic centers in the United States and Japan. Data on demographics, procedural performance, histopathology, and clinical follow-up were collected and analyzed retrospectively.

Results

Porcine study: In total, 12 ESDs were performed in random order in 3 live pigs. ESDs performed with TW had significantly shorter submucosal dissection time (7.0 ± 1.9 minutes vs 18.3 ± 3.4 minutes; P < 0.001) and shorter total ESD time (21.5 ± 4.1 minutes vs 29.5 ± 7.7 minutes; P= 0.049). TW was successfully deployed in all 103 study patients. The median device deployment time was 2 minutes (2, 3.0), and the median procedure time was 100.5 (65.50, 175.75) minutes. En-bloc and R0 resection rates were 98.1% (101/103) and 90.29% (93/103), respectively. The median ease of deployment and retrieval of the device on a 100-mm visual analog scale was 100 (80, 100). The median degree to which the device improved ease of procedure was 90 (77.5, 100). No adverse events related to the TW were seen.

Conclusion

The TW device was safe and efficient to use in ESD.