iGIE : innovation, investigation and insights · 2024
Efficacy and safety of over-the-scope endoscopic suturing device for closure of defects after endoscopic submucosal dissection: a systematic review and meta-analysis.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Vongsavath Tahne, Tun Kyaw Min, Saghir Syed Mohsin, Bapaye Jay, Verma Renuka, Lo Chun-Han, Gill Ahmad, Dhindsa Banreet Singh, Chandan Saurabh, Adler Douglas G
Аннотация
BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is used for closure of GI lesions after endoscopic resection techniques such as EMR. Generally, a large defect is left that can increase the risk of postprocedural bleeding or perforation, and it has been managed by techniques such as endoscopic placement of clips to reapproximate the defect edges. An over-the-scope suturing system (OSS), OverStitch created by Apollo Endosurgery, has been designed for similar utility in ESD closure. The goal of its design is to achieve full-thickness closure and exchange of suture without endoscopic removal. The goal of this study was to evaluate the technical success and efficacy of using OSS in the closure of ESD.
METHODS: A comprehensive literature review across multiple databases was performed. Studies including OverStitch and ESD information were evaluated, with 7 articles meeting predetermined eligibility of quality for inclusion. Statistical analysis was completed by using CMA version 3.0 software (Biostat, Englewood, NJ, USA). The primary evaluated end point was technical success and efficacy of instrument use in patients undergoing ESD closure with OSS. The secondary evaluated end point was the overall rate of adverse events related to the use of OSS.
RESULTS: Overall, the pooled rates for instrumental efficacy and technical success were 95.8% (95% CI [confidence interval], 80.6%-99.2%; P = .04) and 99.2% (95% CI, 79.8%-100.0%; P = 1.00), respectively. The pooled rate of adverse events was .9% (95% CI, 0%-24.8%; P = .99) with pain reported as the most common adverse event.
CONCLUSIONS: OSS seems to be an effective and safe tool in the closure of defects after ESD. However, its design also makes it large and difficult to maneuver. Although it allows for replacement of the suture kit without endoscopic removal, there have been multiple reported episodes of device failure. Further randomized controlled trials are warranted as OSS becomes more widely used.
METHODS: A comprehensive literature review across multiple databases was performed. Studies including OverStitch and ESD information were evaluated, with 7 articles meeting predetermined eligibility of quality for inclusion. Statistical analysis was completed by using CMA version 3.0 software (Biostat, Englewood, NJ, USA). The primary evaluated end point was technical success and efficacy of instrument use in patients undergoing ESD closure with OSS. The secondary evaluated end point was the overall rate of adverse events related to the use of OSS.
RESULTS: Overall, the pooled rates for instrumental efficacy and technical success were 95.8% (95% CI [confidence interval], 80.6%-99.2%; P = .04) and 99.2% (95% CI, 79.8%-100.0%; P = 1.00), respectively. The pooled rate of adverse events was .9% (95% CI, 0%-24.8%; P = .99) with pain reported as the most common adverse event.
CONCLUSIONS: OSS seems to be an effective and safe tool in the closure of defects after ESD. However, its design also makes it large and difficult to maneuver. Although it allows for replacement of the suture kit without endoscopic removal, there have been multiple reported episodes of device failure. Further randomized controlled trials are warranted as OSS becomes more widely used.