Esophageal covered stent fixation using an endoscopic over-the-scope clip. Mechanical proof of the concept and first clinical experience

Endoscopic suturing reduces stent migration, but is challenging and time-consuming. We compare endoscopic suturing versus anchoring with a novel over-the-scope clip (Padlock) to fix esophageal stents. Additionally, the first clinical case of Padlock stent fixation is reported. A fully covered esophageal stent was placed in 11 pigs and fixed with one figure-of-eight suture (n = 5) or with a Padlock (n = 4) or not fixed (controls; n = 2). The force required to mobilize the stent was recorded. Clinical case: an esophageal stent was fixed with a Padlock and endoscopically removed 1 month later, in an 82-year-old patient. Mean force (newton) to mobilize the stent was similar after suturing and Padlock fixation (23.99 +/- A 14.91 vs. 19.97 +/- A 7.62; p = 0.32). In controls was 7 and 11 Newtons. Suturing time (seconds) was longer than Padlock application (455.4 +/- A 144.83 vs. 155 +/- A 12.9; p = 0.002). Clinical case: stent fixation was feasible and uncomplicated. Removal was easy, and only mild bleeding occurred. Padlock is faster than endoscopic suturing and achieves similar stent fixation. The first clinical case confirms the feasibility of the method.