Yunho Jung1, Masayuki Kato, Jongchan Lee, Mark A Gromski, Ram Chuttani, Kai Matthes. 1. Yunho Jung, Masayuki Kato, Jongchan Lee, Mark A Gromski, Ram Chuttani, Kai Matthes, Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, United States.
Abstract
AIM: To evaluate the efficacy of circumferential endoscopic mucosal resection (EMR) with a tissue-anchoring device in comparison to forceps precut EMR and conventional endoscopic submucosal dissection (ESD). METHODS: The study was designed as a prospective, randomized, ex vivo study. Fresh ex vivo specimens were harvested from adult white Yorkshire pigs weighing 30-50 kg. Seventy-five standardized, artificial lesions measuring 3 cm × 3 cm were created by methylene blue tattoo at the greater curvature in fresh ex vivo stomachs using the EASIE-R simulator platform (Endosim LLC, Berlin, MA, United States). The three advanced endoscopists performed the three resection techniques such as circumferential EMR using the tissue-anchoring device (TA-EMR), forceps precut EMR (FP-EMR), and endoscopic submucosal dissection. The endoscopists and the type of cutting methods were determined randomly by grouped randomized selection. The resection bed was grossly inspected to determine whether the lesion was resected "en-bloc" (defined as no remaining mucosal tattoo remaining on specimen). The resection bed was also probed for evidence of perforation. The procedural time of circumferential resection, submucosal dissection, and injection frequency were recorded by an independent observer. RESULTS: All 75 created lesions were successfully resected by three advanced endoscopists using the three techniques. The mean ± SD size of resected specimens (long axis) were 39.5 ± 5.6 mm, 36.5 ± 7.3 mm, and 44.6 ± 5.6 mm for TA-EMR, FP-EMR, and ESD respectively. The overall mean dissection time of both the TA-EMR and FP-EMR was significant shorter than ESD (TA-EMR: 5.1 ± 3.3 min, FP-EMR: 3.5 ± 2.0 min vs ESD: 15.8 ± 9.5 min, P < 0.001, P < 0.001). The overall mean total procedure time of both the tissue-anchoring and forceps circumferential EMR was significantly shorter than ESD (TA-EMR: 17.5 ± 6.0 min, FP-EMR: 16.6 ± 6.6 min vs ESD: 28.6 ± 13.9 min, P < 0.001, P < 0.001). The en-bloc resection rate of ESD was 100% (25/25) and the en-bloc resection rate of the TA-EMR (84.0%, 21/25) was higher than for the FP-EMR (60.0%, 15/25), yet not statistically significant (P = 0.18). The perforation rate of each technique was 8.0% (2/25). CONCLUSION: TA-EMR appears to be quicker than ESD, and there was a trend towards improved en bloc resection rate with the TA-EMR when compared to the FP-EMR.
RCT Entities:
AIM: To evaluate the efficacy of circumferential endoscopic mucosal resection (EMR) with a tissue-anchoring device in comparison to forceps precut EMR and conventional endoscopic submucosal dissection (ESD). METHODS: The study was designed as a prospective, randomized, ex vivo study. Fresh ex vivo specimens were harvested from adult white Yorkshire pigs weighing 30-50 kg. Seventy-five standardized, artificial lesions measuring 3 cm × 3 cm were created by methylene blue tattoo at the greater curvature in fresh ex vivo stomachs using the EASIE-R simulator platform (Endosim LLC, Berlin, MA, United States). The three advanced endoscopists performed the three resection techniques such as circumferential EMR using the tissue-anchoring device (TA-EMR), forceps precut EMR (FP-EMR), and endoscopic submucosal dissection. The endoscopists and the type of cutting methods were determined randomly by grouped randomized selection. The resection bed was grossly inspected to determine whether the lesion was resected "en-bloc" (defined as no remaining mucosal tattoo remaining on specimen). The resection bed was also probed for evidence of perforation. The procedural time of circumferential resection, submucosal dissection, and injection frequency were recorded by an independent observer. RESULTS: All 75 created lesions were successfully resected by three advanced endoscopists using the three techniques. The mean ± SD size of resected specimens (long axis) were 39.5 ± 5.6 mm, 36.5 ± 7.3 mm, and 44.6 ± 5.6 mm for TA-EMR, FP-EMR, and ESD respectively. The overall mean dissection time of both the TA-EMR and FP-EMR was significant shorter than ESD (TA-EMR: 5.1 ± 3.3 min, FP-EMR: 3.5 ± 2.0 min vs ESD: 15.8 ± 9.5 min, P < 0.001, P < 0.001). The overall mean total procedure time of both the tissue-anchoring and forceps circumferential EMR was significantly shorter than ESD (TA-EMR: 17.5 ± 6.0 min, FP-EMR: 16.6 ± 6.6 min vs ESD: 28.6 ± 13.9 min, P < 0.001, P < 0.001). The en-bloc resection rate of ESD was 100% (25/25) and the en-bloc resection rate of the TA-EMR (84.0%, 21/25) was higher than for the FP-EMR (60.0%, 15/25), yet not statistically significant (P = 0.18). The perforation rate of each technique was 8.0% (2/25). CONCLUSION: TA-EMR appears to be quicker than ESD, and there was a trend towards improved en bloc resection rate with the TA-EMR when compared to the FP-EMR.
Authors: M Miyata; Y Yokoyama; N Okoyama; T Joh; K Seno; M Sasaki; H Ohara; T Nomura; K Kasugai; M Itoh Journal: Endoscopy Date: 2000-10 Impact factor: 10.093
Authors: S Nakamoto; Y Sakai; J Kasanuki; F Kondo; Y Ooka; K Kato; M Arai; T Suzuki; T Matsumura; D Bekku; K Ito; T Tanaka; O Yokosuka Journal: Endoscopy Date: 2009-08-13 Impact factor: 10.093