stentfix OTSC® – Study shows successful prevention of FCSEMS migration in the GI tract

A multicenter experience in 31 patients at high-risk of fully-covered self-expandable metal stent (FCSEMS) migration revealed a stent migration rate of only 3.2% (1/31; 95%CI 0–9.4) and 100% technical success with the dedicated stentfix OTSC System. No adverse events were observed.

R. Manta et al., Gastroenterology and Digestive Endoscopy Unit, Santa Maria della Misericordia Hospital, Perugia, Italy, investigated the use of the innovative stentfix OTSC System for preventing FCSEMS migration in the gastrointestinal (GI) tract. FCSEMS are commonly used for endoscopic management of GI lesions, but stent migration can occur in up to one-third of patients. The stentfix OTSC clip has been specifically designed to prevent FCSEMS migration and improve patient outcomes.

The aim of the study was to evaluate technical success (defined as successful positioning of the stentfix OTSC) and stent migration (documented at X-ray or endoscopy) with the stentfix OTSC System. Patients were followed to assess success and delayed adverse events (AEs).

In total, 31 patients (84% male; mean age 68.6 ± 10.7 years) were enrolled from four medical centers between December 2019 and April 2021. stentfix OTSC was used to anchor FCSEMS for different indications in the GI tract (n=14 stricture, n=10 fistula, n=5 anastomotic leakage and n=2 perforation). The stent was placed in 28 cases in the upper GI tract and in 3 cases in the lower GI tract. Technical success was achieved in 100% of cases. No AEs were observed. Stent migration was observed in only one patient (3.2%; 95%CI 0–9.4). In this patient (with abundant ascites due to peritoneal carcinomatosis), migration of an antroduodenal stent fixed at the proximal side occurred 3 days after placement; the high pressure likely contributed to increase peristalsis. FCSEMS was removed at various intervals (between 4–16 weeks), depending on the underling disease and the general condition of patient.

The authors concluded that the stentfix OTSC System is a safe and effective tool for fixation of FCSEMS in the gastrointestinal tract.

Manta R, Del Nero L, Todd B, Parodi A, De Ceglie A, Zito F, Pasquale L, Zullo A, Conio M. Newly designed OTS Clip for preventing fully-covered self-expandable metal stent migration in the gastrointestinal tract. Endosc Int Open. 2023 Mar 24;11(3):E284-E287. doi: 10.1055/a-2032-4147.