United European gastroenterology journal · 2026
Was Motorized Spiral Enteroscopy Too Risky? A Systematic Review and Meta-Analysis Including German Registry Data.
СтатьяСистематический обзорМетаанализНазвание и аннотация: Перевод пока не подготовлен
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Steinbrück Ingo, Kuellmer Armin, Faiss Siegbert, Buchholz Hendrik, Lewerenz Björn, Fitting Daniel, Wiedbrauck Felix, Hollerbach Stephan, Schmidt Arthur, Rey Johannes Wilhelm, Kirstein Martha M, Dumoulin Franz-Ludwig, Wittich Fabian Maximilian, Wannhoff Andreas, Pohl Jürgen, Friesicke Matthias, Rempel Viktor, Allgaier Hans-Peter, Wiessner Christian, Rösch Thomas
Аннотация
BACKGROUND AND STUDY AIMS: Motorized spiral enteroscopy (MSE) was introduced as a major advancement in small-bowel enteroscopy, enabling higher complete enteroscopy rates with shorter procedure times. However, after a fatal adverse event (AE) involving severe esophageal injury, the device was withdrawn from the market in July 2023. This raised questions about whether earlier safety signals were missed.
METHODS: We conducted a systematic review and meta-analysis comparing MSE with balloon-based enteroscopy (double-balloon [DBE] and single-balloon enteroscopy [SBE], analyzed together). Outcomes included overall AEs, serious AEs (SAEs), and data collection quality. Results from the German PowerSpiral Registry were included, comprising 647 MSE procedures in 523 patients (January 2020-July 2023) before registry closure following device withdrawal.
RESULTS: Thirteen MSE studies (including the registry) and 55 DBE/SBE studies were analyzed, totaling 12,559 enteroscopies (2024 MSE; 10,535 DBE/SBE). MSE showed significantly higher rates of AEs (10.8% vs. 1.6%) and SAEs (1.5% vs. 0.4%). Procedure-related SAEs were also more frequent with MSE (1.1% vs. 0.3%). Esophageal injury (0.10% vs. 0.009%) and intestinal perforation (0.5% vs. 0.1%) occurred more often with MSE, whereas acute pancreatitis (0.05% vs. 0.27%) and esophageal perforation (0% vs. 0.02%) were more common with DBE/SBE. AE reporting for MSE was detailed, but structured follow-up and reliable case tracking were inconsistent.
CONCLUSIONS: MSE was associated with higher AE and SAE rates than balloon enteroscopy. These findings highlight the need for cautious adoption, rigorous safety monitoring, and more robust AE reporting when introducing innovative endoscopic technologies.
STUDY REGISTRATION: The prospective and retrospective cohort studies were registered in the German Registry of Clinical Studies (DRKS), namely DRKS00026990 and DRKS00028571.
METHODS: We conducted a systematic review and meta-analysis comparing MSE with balloon-based enteroscopy (double-balloon [DBE] and single-balloon enteroscopy [SBE], analyzed together). Outcomes included overall AEs, serious AEs (SAEs), and data collection quality. Results from the German PowerSpiral Registry were included, comprising 647 MSE procedures in 523 patients (January 2020-July 2023) before registry closure following device withdrawal.
RESULTS: Thirteen MSE studies (including the registry) and 55 DBE/SBE studies were analyzed, totaling 12,559 enteroscopies (2024 MSE; 10,535 DBE/SBE). MSE showed significantly higher rates of AEs (10.8% vs. 1.6%) and SAEs (1.5% vs. 0.4%). Procedure-related SAEs were also more frequent with MSE (1.1% vs. 0.3%). Esophageal injury (0.10% vs. 0.009%) and intestinal perforation (0.5% vs. 0.1%) occurred more often with MSE, whereas acute pancreatitis (0.05% vs. 0.27%) and esophageal perforation (0% vs. 0.02%) were more common with DBE/SBE. AE reporting for MSE was detailed, but structured follow-up and reliable case tracking were inconsistent.
CONCLUSIONS: MSE was associated with higher AE and SAE rates than balloon enteroscopy. These findings highlight the need for cautious adoption, rigorous safety monitoring, and more robust AE reporting when introducing innovative endoscopic technologies.
STUDY REGISTRATION: The prospective and retrospective cohort studies were registered in the German Registry of Clinical Studies (DRKS), namely DRKS00026990 and DRKS00028571.