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Double layer stent for the treatment of leaks and fistula after upper gastrointestinal oncologic surgery: a retrospective study


Anastomotic dehiscence is one of the most morbidity related and deadly complication after foregut oncologic surgery. The aim of the study is to evaluate the effectiveness of double layer stents (Niti-S™ Beta™ Esophageal Stent) in the management of dehiscences after upper gastrointestinal oncologic surgery. We retrospectively studied consecutive patients who underwent Niti-S™ Beta™ esophageal stent placement from June 2014 to September 2019 for the treatment of anastomotic leaks/fistula following esophagectomy or gastrectomy for cancer. Univariate two-sided logistic regression analysis was used to evaluate possible predictors of successful anastomotic leak/fistula closure. A total of 37 patients were studied and 75 stents were positioned in these patients during the endoscopic procedures. Effective leak/fistula closure was obtained in 23/37 (62.2%). No technical endoscopic failure or complications ensued during the placing of the devices. Regarding delayed complications, migration was observed in 17/75 (22.7%) procedures and stent leaking in 29/75 (38.6%). Three variables significantly favoured stent treatment failure, namely previous neoadjuvant therapy (OR 9.3, P = 0.01), fistula (instead of leak) (OR 6.5, P = 0.01), and stent leak (OR 17.0, P = 0.01). Placement of Beta Niti-S esophageal stent is a safe and effective method that could be considered for the management of leaks and fistula after upper gastrointestinal cancer. Crucial points in the management of post-surgical leaks with this technique are the prompt recognition of leaks and fistula, the prompt endoscopic/radiologic drain of collection and the choice of adequate size of the stent.

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Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.


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No funding was received for conducting this study.

Author information




FVM, DE and LF contributed to the study conception and design. Material preparation, data collection and analysis were performed by FVM, DE, GNES, MG and LF. The first draft of the manuscript was written by FVM, DE and LF and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Francesco Vito Mandarino.

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The authors have no conflicts of interest to declare that are relevant to the content of this article.

Ethical approval

The study was approved by local Ethical Committee (N° LEAK 0.1).

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Informed consent was obtained from the patients.

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Mandarino, F.V., Esposito, D., Spelta, G.N.E. et al. Double layer stent for the treatment of leaks and fistula after upper gastrointestinal oncologic surgery: a retrospective study. Updates Surg (2021).

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  • Metal stent
  • Endoscopy
  • Esophageal leak
  • Esophagectomy