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DOI: 10.1055/a-2675-1616
Endoscopic management of refractory gastrointestinal–tracheobronchial fistulas with two novel occluders: a comparative cohort study
Supported by: National Natural Science Foundation of China No. 82470593 and No. 82200626
Supported by: Natural Science Foundation of Jiangsu Province BK20220720
Supported by: Medical Key Discipline Foundation of Jiangsu Province ZDXK202206 Clinical Trial: Registration number (trial ID): ChiCTR2500095557, Trial registry: Chinese Clinical Trial Registry (http://www.chictr.org/), Type of Study: Retrospective

Abstract
Background
Refractory gastrointestinal (GI)–tracheobronchial fistulas are challenging to manage. This study compared the outcomes of two novel occluders specifically designed for endoscopic occlusion of GI–tracheobronchial fistulas.
Methods
In this retrospective cohort study, 86 patients with refractory GI–tracheobronchial fistulas who underwent endoscopic occlusion using either a double umbrella-shaped (DU; n = 36) or mushroom umbrella-shaped (MU; n = 50) occluder were included. The primary outcome was sustained occlusion. Secondary outcomes included technical success, adverse events (AEs), occluder-related discomfort, and percentage weight gain.
Results
The DU occluder was associated with a higher risk of occlusion failure compared with the MU occluder (hazard ratio [HR] 2.67, 95%CI 1.24–5.73; P = 0.01), with a 12-month cumulative sustained occlusion probability of 65.5% (95%CI 51.3%–83.5%) versus 82.1% (95%CI 71.4%–94.3%), respectively. Esophageal wall injury requiring occluder removal occurred in six DU patients, but in none of the MU group. Technical success was 100% in both groups. All procedure-related AEs were mild, occurring in five DU (13.9%) and three MU patients (6.0%).
Conclusions
The MU occluder showed greater potential for sustained occlusion than the DU occluder and may be a viable option for refractory GI–tracheobronchial fistulas, although further prospective studies are needed.
Publication History
Received: 25 February 2025
Accepted after revision: 18 July 2025
Article published online:
19 August 2025
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