Newly developed self-expandable Niti-S MD colonic metal stent for malignant colonic obstruction

Colonic stents are increasingly used to treat acute malignant colonic obstructions. The WallFlex and Niti-S D type stents are the commonly used self-expandable metallic stents available in Japan since 2012. WallFlex stent has a risk of stent-related perforation because of its axial force, while the Niti-S D type stent has a risk of obstructive colitis because of its weaker radial force. Niti-S MD type stents not only overcome these limitations but also permit delivery through highly flexible-tipped smaller-caliber colonoscopes.

To compare the efficacy and safety of the newly developed Niti-S MD type colonic stents.

This single-center retrospective observational study included 110 patients with endoscopic self-expandable metallic stents placed between November 2011 and December 2018: WallFlex (Group W, n = 37), Niti-S D type (Group N, n = 53), and Niti-S MD type (Group MD, n = 20). The primary outcome was clinical success, defined as a resolution of obstructive colonic symptoms, confirmed by clinical and radiological assessment within 48 h. The secondary outcome was technical success, defined as accurate stent placement with adequate stricture coverage on the first attempt without complications.

The technical success rate was 100% in Groups W, N, and MD, and the overall clinical success rate was 89.2% (33/37), 96.2% (51/53), and 100% (20/20) in Groups W, N, and MD, respectively. Early adverse events included pain (3/37, 8.1%), poor expansion (1/37, 2.7%), and fever (1/37, 2.6%) in Group W and perforation due to obstructive colitis (2/53, 3.8%) in Group N (likely due to poor expansion). Late adverse events (after 7 d) included stent-related perforations (4/36, 11.1%) and stent occlusion (1/36, 2.8%) in Group W and stent occlusion (2/51, 3.9%) in Group N. The stent-related perforation rate in Group W was significantly higher than that in Group N (P < 0.05). No adverse event was observed in Group MD.

In our early and limited experience, the newly developed Niti-S MD type colonic stent was effective and safe for treating acute malignant colonic obstruction.