Photo Credit: Science Direct

The following is a summary of “Endoscopic Suturing to Prevent Migration of Esophageal Fully Covered Self-Expanding Metal Stents: A Randomized Controlled Trial,” published in the February 2025 issue of the Gastrointestinal Endoscopy by Singh et al.

Fully covered self-expanding metal stents (FC-SEMSs) are widely utilized for the management of esophageal strictures; however, high migration rates remain a significant challenge. Endoscopic suture fixation has been proposed as a potential strategy to mitigate this issue. This randomized controlled trial aimed to compare stent migration rates, adverse events, and cost-effectiveness between FC-SEMS placement with and without endoscopic suturing.

A single-center, randomized controlled trial was conducted from July 2021 to December 2022, enrolling adult patients who underwent FC-SEMS placement for esophageal strictures. Patients were randomly assigned (1:1 stratified randomization based on benign or malignant etiology) to receive FC-SEMS placement either with endoscopic suture fixation or without fixation. Investigators were blinded to the randomization sequence, and both patients and statistical analysts were blinded to intervention allocation. The primary outcome was the rate of stent migration. Secondary outcomes included other stent-related adverse events, technical success, procedure duration, time to migration, premature stent removal due to adverse events, and cost-effectiveness of endoscopic suturing. A cost-effectiveness analysis (CEA) was performed to compare the financial feasibility of endoscopic suturing versus FC-SEMS placement alone.

A total of 46 patients were included in the study, with 24 patients assigned to the fixation group and 22 to the non-fixation group. In the intention-to-treat analysis, the migration rate of FC-SEMS was significantly lower in the fixation group than in the non-fixation group (Risk Ratio: 0.28, 95% CI: 0.11–0.74, p = 0.008). Secondary outcomes were largely similar between the two groups, with the exception of procedure duration, which was significantly longer in the fixation group (p = 0.001). Cost-effectiveness analysis revealed that endoscopic suturing was a financially viable intervention for preventing stent migration compared to FC-SEMS placement alone. Given the clear inferiority of the primary outcome in the non-fixation group, the trial was terminated early following interim analysis.

In conclusion, endoscopic suture fixation significantly reduces the risk of FC-SEMS migration without increasing procedure-related complications, though it does result in a longer procedure duration. Furthermore, cost-effectiveness analysis supports the economic feasibility of endoscopic suturing as a viable method for reducing stent migration. These findings provide strong evidence for the adoption of endoscopic suturing as a preferred strategy in clinical practice to improve outcomes in patients undergoing esophageal FC-SEMS placement. Further comparative studies evaluating alternative fixation techniques are warranted to refine esophageal stent management and optimize patient care.

Source: giejournal.org/article/S0016-5107(25)00139-7/abstract