Hytham K S Hamid1, Sameh H Emile2, Alan A Saber3, Mürşit Dincer4, Diogo T H de Moura5, Lennard P L Gilissen6, Majid A Almadi7, Mauro Montuori8, Michel Vix9, Luis G S Perisse10, Nicolás Quezada11, Fabio Garofalo12, Radu Pescarus13. 1. Department of Surgery, Soba University Hospital, Khartoum, Sudan. kujali2@gmail.com. 2. Colorectal Surgery Unit, Department of General Surgery, Mansoura University Hospitals, Mansoura University, Mansoura, Egypt. 3. Bariatric Surgery Unit, Department of Surgery, Newark Beth Israel Medical Center, Newark, NJ, USA. 4. Department of General Surgery, School of Medicine, Firat University, Elazig, Turkey. 5. Department of Surgery, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. 6. Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands. 7. Division of Gastroenterology, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia. 8. Bariatric Surgery Unit, Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy. 9. Department of General, Digestive and Endocrine Surgery, IRCAD-IHU, University of Strasbourg, Strasbourg, France. 10. Digestive Endoscopy Unit, Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil. 11. Department of Digestive Surgery, School of Medicine, Pontifical Catholic University of Chile, Santiago, Chile. 12. Department of Surgery, Ospedale Régionale di Lugano (EOC), Lugano, Switzerland. 13. Division of Bariatric Surgery, Department of Surgery, Sacré-Cœur de Montréal Hospital, University of Montréal, Montreal, Canada.
Abstract
OBJECTIVE: Recently, there has been a burgeoning interest in the utilization of customized bariatric stents (CBS) for management of sleeve gastrectomy leak (SGL). We aimed to conduct a proportion meta-analysis to evaluate the cumulative efficacy and safety of these new stents and to compare them with the conventional esophageal stents (CES). METHODS: A systematic literature search of the PubMed, Cochrane Library, Scopus, Web of Science and Google Scholar databases was conducted through May 1, 2020. Primary outcomes were technical and clinical success and post-procedure adverse events of CBS and CES. Secondary outcomes were number of stents and endoscopic sessions per patient, and time to leak closure. A proportion meta-analysis was performed on outcomes using a random-effects model, and the weighted pooled rates (WPRs) or mean difference with 95% confidence interval (CI) were calculated. RESULTS: The WPR with 95% CI of technical success, clinical success, and stent migration for CBS were 99% (93-100%) I2 = 34%, 82% (69-93%) I2 = 58%, and 32% (17-49%), I2 = 69%, respectively. For CES, the WPR (95% CI) for technical success, clinical success, and stent migration were 100% (97-100%) I2 = 19%, 93% (85-98%) I2 = 30%, and 15% (7-25%), I2 = 41%, respectively. Adverse events other than migration were very low with both types of stents. On proportionate difference, CBS had lower clinical success (11%) and higher migration rate (17%) in comparison to CES. In successfully treated patients, CBS was associated with lower mean number of stents and endoscopic sessions, and shorter time to leak closure compared to CES. The overall quality of evidence was very low. CONCLUSIONS: In treatment of SGL, there is very low level evidence that CES are superior to CBS in terms of clinical success and migration rate, though may require more stent insertions and endoscopic procedures. The evidence however remains very uncertain. Perhaps relevant to some types of stents, CBS are promising; however design modification is strongly recommended to improve outcomes.
OBJECTIVE: Recently, there has been a burgeoning interest in the utilization of customized bariatric stents (CBS) for management of sleeve gastrectomy leak (SGL). We aimed to conduct a proportion meta-analysis to evaluate the cumulative efficacy and safety of these new stents and to compare them with the conventional esophageal stents (CES). METHODS: A systematic literature search of the PubMed, Cochrane Library, Scopus, Web of Science and Google Scholar databases was conducted through May 1, 2020. Primary outcomes were technical and clinical success and post-procedure adverse events of CBS and CES. Secondary outcomes were number of stents and endoscopic sessions per patient, and time to leak closure. A proportion meta-analysis was performed on outcomes using a random-effects model, and the weighted pooled rates (WPRs) or mean difference with 95% confidence interval (CI) were calculated. RESULTS: The WPR with 95% CI of technical success, clinical success, and stent migration for CBS were 99% (93-100%) I2 = 34%, 82% (69-93%) I2 = 58%, and 32% (17-49%), I2 = 69%, respectively. For CES, the WPR (95% CI) for technical success, clinical success, and stent migration were 100% (97-100%) I2 = 19%, 93% (85-98%) I2 = 30%, and 15% (7-25%), I2 = 41%, respectively. Adverse events other than migration were very low with both types of stents. On proportionate difference, CBS had lower clinical success (11%) and higher migration rate (17%) in comparison to CES. In successfully treated patients, CBS was associated with lower mean number of stents and endoscopic sessions, and shorter time to leak closure compared to CES. The overall quality of evidence was very low. CONCLUSIONS: In treatment of SGL, there is very low level evidence that CES are superior to CBS in terms of clinical success and migration rate, though may require more stent insertions and endoscopic procedures. The evidence however remains very uncertain. Perhaps relevant to some types of stents, CBS are promising; however design modification is strongly recommended to improve outcomes.
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