THE USE OF BIODEGRADABLE ELLA STENT IN THE TREATMENT OF BENIGH ESOPHAGEAL STENOSIS

Aims:

A refractory or recurrent esophageal stenosis is defined when a diameter of the lumen of 14 mm or more can not be obtained over 5 dilatations at 2 week intervals or when it can not be maintained for 4 weeks.

It is often treated with temporary stent placement. We used the biodegradable stent, the BD SX-ELLA stent. It is made of uncovered woven polydioxanone (PDS). It has shape memory and degrades completely over 12 weeks by hydrolysis in acid pH.

Migration has no clinical impact.

Methods:

We performed a descriptive, retrospective observational study of 9 patients seen in our institution since 2011 treated with implant of Biodegradable Self-expandable Stent.

Results:

9 patients were included, one was lost on follow-up, 8 (6 M/2F) remained. The median age was 72,5 (range 41 – 96), 4 had a post-operative stenosis (50%) 3 had a peptic stenosis (37,5%), 1 had a scleroderma (12,5%).

6 (75%) had already been treated with dilation (2/6), SEMS (1/6) or both (3/6). A total of 2 patients (25%) were totally naif to previous treatments.

20 reabsorbable stents were used, 19/20 were successfully inserted (technical success 95%), 6 patients had a clinical and endoscopic resolution at the end of follow-up (75%) 1 had a neoplastic relapse and 1 underwent the positioning of a SEMS after the treatment with 1 Ella.

The most common adverse event was the formation of granulation tissue creating a substenosis in 2 (10%) patients (treated with another Ella stent). Self limiting bleeding was seen in 1 (5%) patient and 1 (5%) patient complained with pain.

Conclusions:

The insertion of a reabsorbable stent is a safe procedure, clinical success rate of 75% but with a multiple number of devices/patient needed, the use of a single stent is seldom sufficient. Ella stent should be considered as a therapy to be used in repeated sessions similarly to dilation.