Pii: S1010-7940(01)00867-3

Objective: Any treatment of tracheo–esophageal fistulae in end-stage malignant stenosis of the esophagus must be weighed against associated morbidity and mortality. In a prospective study we investigated benefits and risks of the use of one type of coated, self-expandable stent. Patients and methods: We treated four male and two female patients, (mean age 68.3 years, range: 38–90 years), with malignant esophago–tracheal fistula non-resectable due to advanced tumour stage and/or functional reasons. All were in a poor general condition suffering from aspiration pneumonia and malnutrition. Four out of the six patients had had one or multiple extraor endoluminal palliative treatments at a mean interval of 191 days (range: 7 days–15 ms) since the last intervention. The fistulae were sealed by using a covered, selfexpandable stent (ULTRAFLEX esophageal stent system, Microinvasive, Boston Scientific Corporation, Boston, MA). Results: Stenting did not cause any technical problems and all fistulae were successfully sealed in a one-step procedure. The median hospital stay was 4.6 days (range: 3–9 days). Except for one late stent induced recurrent fistula treated by re-stenting and tracheostomy, we did not observe any stent associated complications. Five patients died of tumour generalization. The median survival of the patients who died was 78 days (range: 35– 129 days). One patient is alive and well at 120 days after stenting. Conclusion: In spite of the small number of patients the results suggest that this type of stent represents a safe and efficient approach for palliative endoscopic treatment of this high risk group. Local pretreatment does not preclude the successful use of the self-expandable coated stent. q 2001 Elsevier Science B.V. All rights reserved.