Prevalence of Adverse Events and a Newly-Developed Major Adverse Event Evaluation System for STER: Large Cohort Study of 1435 Cases 21 Aug 2021 10:36 10:44

Prevalence of Adverse Events and a Newly-Developed Major Adverse Event Evaluation System for STER: Large Cohort Study of 1435 Cases 21 Aug 2021 10:36 10:44

(8 mins) - Not available
Quan-Lin Li Presenter

Jia-Qi Xu1, Quan-Lin Li1, Ping-Hong Zhou1 

1Endoscopy Center and Endoscopy Research Institute, Zhongshan Hospital, Fudan University - Zhongshan, Zhongshan Hospital, Shanghai, China

Background/Aims: Submucosal tunneling endoscopic resection (STER) has been widely applied for both diagnosis and treatment of submucosal tumors.This large cohort study aims to elucidate the prevalence of adverse events (AE) and propose a specific major AE evaluation system for STER.

Methods: 1435 patients with esophageal SMT who underwent STER were included in the study at Zhongshan Hospital, Fudan University. Data of clinical characteristics and adverse events were collected and analyzed in depth. AEs were classified by ASGE lexicon grading, Clavien- dindo grading and our major AE evaluation system respectively and consistency in terms of major AE identification were tested. Risk factors were discovered by multivariate analysis.

Results: In 1435 cases of STER, a total of 259 (18%) adverse events were observed, mainly perforation (10.3%), penetration (8.1%) and infection (8.1%). 83 (5.7%) were classified as major AEs (moderate & severe) by ASGE lexicon grading; 32 (2.3%) were classified as major AEs (grade Ⅲ-Ⅴ) by Clavein-Dindo grading; 72 (5.0%) were identified as major AEs by our major AE evaluation system. Cronbach's analysis showed α was 0.853, indicating good consistency among the gradings. By multivariate analysis, distance between tumor and mucosal incision further than 6cm, piecemeal resection, irregular shape, partially extraluminal location and first 1 year operation were predictive factors for major AEs.

Conclusion: STER is a safe technique with 5.0% incidence of major AEs and our major AE evaluation system is consistent with acknowledged ASGE lexicon grading and Clavien-Dindo grading, being more concise and applicable.

Keywords: STER, submucosal tumor, adverse event

 

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