Prospective Multicenter Evaluation of a Novel Low‐Axial‐Force Colonic Stent for Malignant Colorectal Obstruction

Objectives Self‐expandable metal stents (SEMSs) are used as a bridge to surgery (BTS) or for palliation (PAL) in malignant colorectal obstruction, but high axial force may contribute to perforation. We prospectively evaluated the efficacy and safety of the low‐axial‐force Naturfit colonic stent in both settings. Methods This prospective multicenter single‐arm study enrolled 208 patients at 11 Japanese institutions between 2019 and 2022 (BTS, n = 137; PAL, n = 71). The primary endpoint was clinical success of colorectal stenting; secondary endpoints included technical success, adverse events, surgical outcomes after BTS stenting, and 12‐month palliative outcomes. Results Technical success and clinical success of colorectal stenting were both 99.0%, with perforation in three patients (1.4%). In the BTS cohort, clinical success of BTS was 97.1%; no perforations occurred, and early and late adverse‐event rates were 1.5% and 3.7%. All patients underwent elective surgery; colostomy and laparoscopic surgery rates were 4.4% and 87.6%. In the palliative cohort, clinical success of colorectal stenting was 98.6%, late adverse events occurred in 16.9%, and 12‐month overall survival and stent patency were 46.6% and 67.6%. Conclusions Naturfit achieved high technical and clinical success of colorectal stenting with a low perforation rate. These findings support its feasibility for malignant colorectal obstruction in both BTS and palliative settings, although comparative studies are needed to determine relative advantages over other SEMSs.