A systematic review of studies evaluating OTSC application for repair of iatrogenic perforations identified 12 studies with overall 191 patients. Pooled proportion analysis yielded a technical success rate of 89.1 %, and a clinical success rate of 85.2 %. The size of the defect was available in 7 studies and ranged from 2 to 50 mm. Complications related to OTSC application occurred in two patients (1 %).
C. Zhong et al., Affiliated Hospital of Southwest Medical University, Luzhou, China performed a systematic review aiming to evaluate the clinical safety and efficacy of the OTSC System for the management of iatrogenic GI defects. The use of endoscopic procedures such as endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD), endoscopic ultrasound (EUS), endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic full-thickness resection (EFTR) continues to increase worldwide and iatrogenic gastrointestinal (GI) tract perforation is a rare but severe complication of these procedures. The reported incidence in therapeutic endoscopy is between 0.6 % and 5.5 %. The application of the OTSC System is a promising minimally invasive approach for the management of iatrogenic GI defects avoiding surgical intervention.
To perform the systematic review, PubMed, Embase and Cochrane library were searched for eligible articles published between 01/2006 and 12/2018. Two independent reviewers selected the literature according to inclusion and exclusion criteria. Only studies reported in English and series with more than 3 cases were included. Studies describing chronic defects due to percutaneous endoscopic gastrostomy (PEG) extraction were excluded. The statistical analysis was conducted using Comprehensive Meta-Analysis software version 3.0. The overall success rate was estimated based on the pooled proportion with 95 % confidence intervals (CI). Statistical heterogeneity among studies was assessed with the I2 statistic, where an I2 value > 50 % was considered significantly heterogeneous.
Overall 12 studies comprising 191 patients with iatrogenic GI defects were included. The major causes for iatrogenic GI defects were ESD (41.4 %) and EMR (16.2 %), while lesser frequent causes included EFTR (12 %), diagnostic endoscopy (7.9 %), EUS (6.8 %), endoscopic polypectomy (3.7 %), PEG placement or insertion complications (3.7 %), ERCP (2.1 %), and other causes (6.3 %). Localization of defects was in the esophagus (7.3 %), stomach (24.1 %), duodenum (38.2 %), jejunum (1.0 %), cecum (1.6 %), colon (17.2 %), and rectum (10.5 %). The size of the defect was available in 7 studies and ranged from 2 to 50 mm. Pooled proportion analysis yielded a technical success rate of 89.1 % (n = 182 patients; 95 % CI 81.6 % – 93.8 %, I2 = 41.06 %), and a clinical success rate of 85.2 % (n = 170 patients; 95% CI 71.9 % – 92.8 %, l2 = 58.92 %). Complications related to OTSC application occurred in two patients (1 %). None of the included studies reported severe or fatal adverse events.
The authors concluded that endoscopic closure of iatrogenic GI defects with the OTSC System is a safe and effective approach. Further randomized controlled trials are necessary to compare the OTSC System to other treatment modalities.
Endoscopic management of iatrogenic gastrointestinal defects with the Over-The-Scope Clip (OTSC) system: an updated systematic review
Zhong C, Tan S, Ren Y, Luo X, Xu J, Fu X, Peng Y, Tang X.
Minimal invasive therapy & allied technologies 2021; 30 (2): 63-71.