Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker’s diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung’s Disease, and Gastrointestinal neoplasia.
The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.
A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.

本研究旨在验证黏膜下内镜术（submucosal endoscopy）应用于内镜肌切开术、内镜黏膜下剥离术以及组织获取与切除的内镜通路时的有效性与安全性。黏膜下内镜术是近年新兴的胃肠内镜创新技术，其通过剥离胃肠道黏膜下层，在肠壁内开展内镜操作，从而可实现内镜肌切开术（即肌肉切开操作）、用于组织获取与治疗的内镜通路建立，以及癌前与恶性胃肠组织的切除。该技术为多种胃肠疾病的微创管理带来了革命性变革，涉及的疾病包括Zenker憩室、贲门失弛缓症、食管痉挛性疾病、胃轻瘫、食管梗阻、先天性巨结肠病以及胃肠肿瘤。

本研究的核心目标为前瞻性评估黏膜下内镜术后的技术成功率、临床成功率与不良事件发生情况。其中，技术成功率定义为可顺利完成黏膜下内镜操作的能力；临床成功率定义为症状缓解及客观指标改善，客观评估将通过影像学检查、复查内镜、胃肠动力检查以及术后按临床指征常规开展的临床诊疗相关病理学结果进行；不良事件将按照已发表的美国胃肠内镜学会（American Society for Gastrointestinal Endoscopy, ASGE）标准进行记录。

本研究将建立接受黏膜下内镜操作患者的数据库/登记库，以验证上述研究设想。