Masayuki Kato, MD PhD, Yunho Jung, MD, Mark A Gromski, MD, Jongchan Lee, MD, Navaneel Biswas, MD, Chuttani Ram, MD, Kai Matthes, MD PhD. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
INTRODUCTION – Endoscopic submucosal dissection (ESD) has become a standard therapy for early gastric neoplasia in Asian countries. American endoscopists have been deliberate to adopt this therapy for gastric neoplasia, most likely secondary to a lower prevalence of the disease in Western countries and a decreased ability to develop necessary training and proficiency in the technique. From a safety and efficacy standpoint, simulation training may empower the endoscopist to be able to learn the basic tenets of ESD in a safe, controlled and supervised setting before trying first in humans. We report on a study to determine the learning curve of ESD in a simulated setting (EASIE-R, Endosim LLC, Berlin, MA) with an established validated ex-vivo endoscopic model.
MEHODS AND PROCEDURES – The study was designed as a prospective, randomized, ex-vivo study. Ex-vivo porcine organs were utilized in the EASIE-R endoscopic simulator. A total of 150 artificial lesions, each 2×2 cm in size, were created in fresh ex-vivo porcine stomachs at 6 different anatomical sites (fundus anterior and posterior, body anterior and posterior, antrum anterior and posterior). Three examiners (2 beginners, 1 expert) participated in this study. All parameters (procedure time, specimen size, en bloc resection status, perforation) were recorded by an independent observer for each procedure.
RESULTS: All 150 lesions were successfully resected with the use of the ESD technique by the three endoscopists. After 30 ESD cases, the two novices performed ESD with a 100% en-bloc resection rate and without perforation. For the procedures performed by the novices, the total time and perforation rate in the last 30 cases were significantly lower than during the first 30 cases (Table1&Figure1)
CONCLUSIONS: Our study suggests that performing 30 ESD resections in an ex-vivo simulator lead to a significant improvement in safety and efficiency. Future studies should randomize clinical trainees interested in ESD to having simulation training in addition to traditional training versus solely traditional training in ESD, and compare clinical outcomes.
Table1: Comparison between the first 30 cases and the last 30 cases
| ExmaminerA (novice) | First 30cases | Last 30cases | p value | ExmaminerB (novice) | First 30cases | Last 30cases | p value |
| total time, minutes(±SD) | 33.0±2.34 | 18.7±1.47 | <0.0001 | 32.6±3.07 | 11.6±0.91 | <0.0001 | |
| area, cm2(±SD) | 7.9±0.48 | 7.5±0.36 | 0.24 | 9.46±0.54 | 9.67±0.32 | 0.634 | |
| En bloc resection % | 90%(3/30) | 100%(0/30) | 0.039 | 83.3%(26/30) | 100%(0/30) | 0.0096 | |
| perforation % | 16.7%(5/30) | 0%(0/30) | 0.0096 | 10%(3/30) | 100%(0/30) | 0.0389 |
Figure1: The graph of the learning curve for ESD
Session Number: SS05 – Education
Program Number: S028