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Background and aims <p>Endoscopic stenting proved to be a valid surgery-sparing approach for upper gastrointestinal benign pathological conditions, mainly refractory benign strictures and post-surgical transmural defects. Niti-S™ Beta-2™ EKxxxxFNT2 esophageal covered stents were specifically designed to treat these conditions preventing stent migration and embedment.</p> Methods <p>We conducted a monocentric retrospective analysis regarding patients undergoing EKxxxxFNT2 placement for benign indication between January 2019 and December 2024, considering demographic, anthropometric, clinical, and technical variables, and evaluating safety and efficacy profiles.</p> Results <p>A total of 32 patients were included (M 53.1%, median age 63&#xa0;years), 25 (78.1%) post-surgical. Indication for stent placement was leakage in 16/32 cases (50%), and stricture/compression and fistula both in 8/32 (25%). Most frequently applied stent (16/32, 50%) was Niti-S™ Beta-2™ EKxxxxFNT2 esophageal covered stent 24&#xa0;mm × 200&#xa0;mm. Technical success was achieved in 100% of the cases. No periprocedural AEs were registered, 4 stents (12.5%) migrated. Median time to oral refeeding was 4&#xa0;days [IQR 2–10]. Stents were removed after a median time of 34&#xa0;days [IQR 17.3–41.5]. Three patients (9.4%) died before stent removal. Overall clinical success rate was 26/32 cases (81.3%); anastomotic leakage as indication proved to be significantly more frequent among the unsuccessful group [5/6 (83.3%) VS 7/26 (26.9%), <i>p</i> = 0.0012]. Two cases (8%) of stenosis relapse were reported, all successfully endoscopically treated.</p> Conclusions <p>Double-bump antimigratory Niti-S™ Beta-2™ EKxxxxFNT2 esophageal covered stents proved to be a safe, effective, and rapid therapeutic option for patients with complex benign upper gastrointestinal conditions.</p> Graphical Abstract <p></p>

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Endoscopic stenting for benign upper gastrointestinal conditions: safety and efficacy profile of a fully covered double-bump antimigratory stent

  • 期刊论文

  • 发表日期：

    2025年8月25日

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  • C. Gallo,
  • E. Forti,
  • F. Pugliese,
  • L. Dioscoridi,
  • M. Cintolo,
  • G. Bonato,
  • M. Bravo,
  • A. Palermo,
  • E. Manthopoulou,
  • M. Mutignani

摘要

Background and aims

Endoscopic stenting proved to be a valid surgery-sparing approach for upper gastrointestinal benign pathological conditions, mainly refractory benign strictures and post-surgical transmural defects. Niti-S™ Beta-2™ EKxxxxFNT2 esophageal covered stents were specifically designed to treat these conditions preventing stent migration and embedment.

Methods

We conducted a monocentric retrospective analysis regarding patients undergoing EKxxxxFNT2 placement for benign indication between January 2019 and December 2024, considering demographic, anthropometric, clinical, and technical variables, and evaluating safety and efficacy profiles.

Results

A total of 32 patients were included (M 53.1%, median age 63 years), 25 (78.1%) post-surgical. Indication for stent placement was leakage in 16/32 cases (50%), and stricture/compression and fistula both in 8/32 (25%). Most frequently applied stent (16/32, 50%) was Niti-S™ Beta-2™ EKxxxxFNT2 esophageal covered stent 24 mm × 200 mm. Technical success was achieved in 100% of the cases. No periprocedural AEs were registered, 4 stents (12.5%) migrated. Median time to oral refeeding was 4 days [IQR 2–10]. Stents were removed after a median time of 34 days [IQR 17.3–41.5]. Three patients (9.4%) died before stent removal. Overall clinical success rate was 26/32 cases (81.3%); anastomotic leakage as indication proved to be significantly more frequent among the unsuccessful group [5/6 (83.3%) VS 7/26 (26.9%), p = 0.0012]. Two cases (8%) of stenosis relapse were reported, all successfully endoscopically treated.

Conclusions

Double-bump antimigratory Niti-S™ Beta-2™ EKxxxxFNT2 esophageal covered stents proved to be a safe, effective, and rapid therapeutic option for patients with complex benign upper gastrointestinal conditions.

Graphical Abstract