Post written by Shailendra Singh, MD, from West Virginia University, Morgantown, West Virginia, USA.

Fully covered self-expandable metal stents (FC-SEMSs) are widely used in the management of both benign and malignant esophageal disorders, including strictures, leaks, and perforations. However, high migration rates—often exceeding 30% to 60%—remain a major limitation of their use, leading to recurrent procedures, additional health care costs, and patient discomfort. To address this challenge, our randomized controlled trial evaluated whether endoscopic suturing could effectively prevent migration of FC-SEMSs.

Recognizing that endoscopic suturing increases procedural cost, we also performed a parallel cost-effectiveness analysis to assess whether the potential reduction in migration and downstream health care use could offset the higher initial expense. Our goal was to generate high-quality prospective data to guide evidence-based decision-making for stent fixation strategies in clinical practice.

Stent migration remains the most common adverse event after FC-SEMS placement, but use of esophageal stents has continued to rise. Stent use for benign indications has increased more than 8-fold,¹ reflecting expanding therapeutic applications. Despite this growing demand, no formal clinical guidelines exist regarding fixation of esophageal stents to prevent stent migration—largely because of a lack of prospective high-quality evidence.

Endoscopic suture fixation has emerged as a promising strategy to reduce migration. Prior studies, however, have been largely retrospective, single-center, and heterogeneous in technique, leaving uncertainty regarding true clinical benefit and cost-effectiveness. We therefore designed a randomized controlled trial using a standardized suturing technique to rigorously compare migration rates between sutured and nonsutured FC-SEMSs.

In addition, the inclusion of a cost-effectiveness analysis was critical to evaluate whether this approach could be economically justified from a payer perspective, given the significant cost differentials in stent management.

This trial represents the first randomized controlled study to evaluate the efficacy, safety, and cost-effectiveness of endoscopic suture fixation for esophageal FC-SEMSs, to our knowledge. We found that stent migration rates were significantly lower in the sutured (fixation) group than the nonfixation group (RR, .28; 95% CI, .11-.74; P = .008). Importantly, endoscopic suturing was safe and not associated with increased procedure-related adverse events, corroborating findings from prior observational studies.

The cost-effectiveness analysis demonstrated that, despite the upfront procedural cost, suturing was economically favorable because of reductions in repeat interventions, imaging, and hospital use. Together, these findings provide the first prospective randomized evidence supporting the efficacy, safety, and economic value of endoscopic suturing for FC-SEMS fixation, to our knowledge.

Given the high rates and clinical impact of FC-SEMS migration, routine stent fixation should now be strongly considered in appropriate patients. Future research should compare alternative fixation methods (such as clips or tacks), explore novel stent designs and materials, and assess real-world implementation strategies across varied practice settings.

Our study highlights how advanced endoscopic techniques can meaningfully enhance the safety, efficiency, and value of therapeutic endoscopy. Endoscopic suturing provides a practical and reproducible solution to one of the most persistent challenges in esophageal stent therapy. By reducing migration and associated costs, it aligns with the broader goals of improving patient outcomes while optimizing resource use—an important step toward more sustainable, high-value endoscopic care.

Graphical abstract

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1. Chan MQ, Balasubramanian G, Modi RM, et al. Changing epidemiology of esophageal stent placement for dysphagia: a decade of trends and the impact of benign indications. Gastrointest Endosc 2020;92:56-64.e7. ↩︎