Endoscopic suturing to prevent migration of esophageal fully covered self-expanding metal stents: a randomized controlled trial (with video)

Shailendra Singh; Soban Maan; Yousaf Hadi; Rohit Agrawal; Ayowumi A Adekolu; Ethan M Cohen; Faisal S Ali; Wei Fang; Brian Markovich; Matthew Krafft; Shyam Thakkar

doi:10.1016/j.gie.2025.02.037

Endoscopic suturing to prevent migration of esophageal fully covered self-expanding metal stents: a randomized controlled trial (with video)

Gastrointest Endosc. 2025 Feb 28:S0016-5107(25)00139-7. doi: 10.1016/j.gie.2025.02.037. Online ahead of print.

Authors

Affiliations

¹ Gastroenterology and Hepatology Division, Department of Medicine, West Virginia University, Morgantown, West Virginia, USA; Advanced Center for Endoscopy, WVU Medicine, Morgantown, West Virginia, USA. Electronic address: shail121@gmail.com.
² Gastroenterology and Hepatology Division, Department of Medicine, West Virginia University, Morgantown, West Virginia, USA.
³ Division of General Internal Medicine, Department of Medicine, West Virginia University, Morgantown, West Virginia, USA.
⁴ Center for Advanced Endoscopy, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.
⁵ West Virginia Clinical and Translational Science Institute, Morgantown, West Virginia, USA.
⁶ Department of Radiology, West Virginia University, Morgantown, West Virginia, USA.
⁷ Gastroenterology and Hepatology Division, Department of Medicine, West Virginia University, Morgantown, West Virginia, USA; Advanced Center for Endoscopy, WVU Medicine, Morgantown, West Virginia, USA.

PMID: 40024292
DOI: 10.1016/j.gie.2025.02.037

Abstract

Background and aims: High migration rates for fully covered self-expanding metal stents (FC-SEMSs) have been reported in the literature. Endoscopic suture fixation has been explored as a mitigation strategy. This study sought to compare rates of migration and other adverse events after esophageal FC-SEMS placement with and without endoscopic suturing.

Methods: We performed a randomized controlled trial involving adult patients who underwent FC-SEMS placement at our institution for management of esophageal strictures. Patients were randomly allocated (1:1 stratified randomization based on benign or malignant etiology) to undergo FC-SEMS placement with endoscopic suture fixation or FC-SEMS placement alone. All investigators were blinded to the randomization sequence. Patients and statistical analysts were blinded to intervention assignment. Primary outcome was stent migration, and secondary outcomes were other stent-related adverse events, technical success, procedure duration, time to migration, and premature stent removal due to adverse events. A cost-effectiveness analysis was also performed comparing endoscopic suturing with FC-SEMS placement alone.

Results: Between July 2021 and December 2022, a total of 46 patients were enrolled: 24 in the fixation group and 22 in the non-fixation group. In the intention-to-treat analysis, the stent migration rate was significantly lower in the fixation group compared with the non-fixation group (risk ratio, .28; 95% CI, .11-.74; P = .008). All secondary outcomes were similar in both groups, except procedure duration, which was longer in the fixation group (P = .001). Endoscopic suturing was cost-effective for preventing stent migration compared with stent placement alone. The trial was terminated early after an interim analysis clearly showed inferior primary outcomes in the non-fixation group.

Conclusions: These findings support the efficacy, safety, and cost-effectiveness of endoscopic suture fixation for preventing esophageal FC-SEMS migration. Further studies comparing endoscopic suturing and other stent fixation strategies are warranted. (Clinical trial registration number: NCT05082948.).

Associated data

ClinicalTrials.gov/NCT05082948