The Niti-S Oesophageal Stent Reduces Migration Rates in the Palliation of Malignant Dysphagia

Abstract

Background: Self-expanding metal mesh stents (SEMS) are frequently used in the palliation of malignant dysphagia. Our Unit has significant experience of both the Ultraflex stent (Boston Scientific, Natick, Mass) and the Niti-S stent (Taewong Medical, Seoul, Korea). A comparative study was conducted to determine the frequency of stent-related complications with the use of Ultraflex and Niti-S stents in one institution. Methods: Between April 2003 and June 2006 135 patients required SEMS insertion for the palliation of malignant oesophageal obstruction. Individuals received either an Ultraflex (n = 72) or a Niti-S (n = 63) stent. The incidence of complications including retrosternal pain, bleeding, perforation, tumour in-growth or over-growth, migration and 30-day mortality was compared. Results: The age, gender distribution, tumour length, stent length and number of days in hospital after stent insertion were similar between the two groups (median (interquartile range)). The number of patients with retrosternal pain, haematemesis, perforation, bolus obstruction, tumour in-growth or over-growth, and 30-day mortality were also similar. However, the incidence of stent migration was significantly less in the Niti-S stent group. Distal oesophageal and oesophago-gastric junction (OGJ) tumours accounted for 82% of patients receiving an Ultraflex stent and 81% of patients receiving a Niti-S stent. Ultraflex stent migration only occurred in distal oesophageal or junctional cases. Conclusion: The Niti-S stent has design features aimed at reducing stent migration and tumour in-growth. This study has demonstrated a significantly reduced migration rate when compared with the Ultraflex stent with no increase in morbidity or mortality. This finding was sustained even in the distal third and OGJ cancers where the risk of migration is greatest. There was a trend towards reduced tumour in-/over-growth. This study supports the development of a prospective randomised trial. Tabled 1 Ultrafex (n = 72) Niti-S (n = 63) p value Age (years) 74 (62-84) 76 (64-83) n/s Male:female 45:27 44:19 n/s Tumour length (cm) 6 (5-8) 6 (5-9) n/s Distal oesophageal tumour 35 26 n/s OGJ tumour 24 25 n/s Stent length (cm) 9 (7-12) 8 (8-12) n/s Post-stent stay (days) 3 (2-4) 3 (2-5) n/s Tumour in-/over-growth 14 9 n/s Stent migration (all tumours) 8 0 0.02 Stent migration (distal oesophageal tumour) 3 0 n/a Stent migration (OGJ tumour) 5 0 n/a 30-day mortality 2 0 n/a n/s - not significant. n/a - not applicable (numbers too small) Open table in a new tab n/s - not significant. n/a - not applicable (numbers too small)