Evaluating no fixation, endoscopic suture fixation, and an over-the-scope clip for anchoring fully covered self-expandable metal stents in benign upper GI conditions: a comparative multicenter international study (with video)

Abstract

Background and aims: Fully covered self-expandable metal stents (FCSEMSs) are widely used in benign upper GI conditions, but stent migration remains a limitation. An over-the-scope clip (OTSC) device (Stentfix {SF], Ovesco Endoscopy) for stent anchoring has recently been developed. The aim of this study was to evaluate the effect of OTSC fixation on FCSEMS migration rate.

Methods: In this retrospective review of consecutive patients who underwent FCSEMS placement for benign upper GI conditions from January 2011 to October 2022 at 16 centers, the primary outcome was rate of stent migration. The secondary outcomes were clinical success and adverse events.

Results: A total of 311 (no fixation [NF] 122, SF 94, endoscopic suturing [ES] 95) patients underwent 316 stenting procedures. Compared with the NF group (n = 49, 39%), the rates of stent migration were significantly lower in the SF (n = 16, 17%, P = .001) and ES (n = 23, 24%, P = .01) groups. The rates of stent migration were not different between the SF and ES groups (P = .2). On multivariate analysis, SF (odds ratio [OR], 0.34, 95% CI, 0.17-0.70, P < .01) and ES (OR, 0.46, 95% CI, 0.23-0.91; P = .02) were independently associated with decreased risk of stent migration. Compared with the NF group (n = 64; 52%), there were higher rates of clinical success in the SF (n = 64; 68%; P = .03) and ES (n = 66; 69%; P = .02) groups. There was no significant difference in the rates of adverse events among the 3 groups.

Conclusion: Stent fixation using OTSCs is safe and effective at preventing stent migration and may also result in improved clinical response.