Background: Benign cervical anastomotic strictures are a cumbersome entity often requiring repetitive dilatations before a clinical acceptable steady state is achieved.
Objective: The aim of this prospective single center feasibility study was to investigate the safety and efficacy of a biodegradable uncovered expandable stent (SX-ELLA Biodegradable Esophageal Stent BD, ELLA-CS, Hradec Kralove, Czech Republic) for the treatment of anastomotic esophageal strictures. Ten patients with dysphagia grade =2 (ability to eat semisolids, to swallow liquids or having complete obstruction) due to benign anastomotic esophageal strictures who fulfilled the patient selection criteria were included.
Main Outcome Measures: The primary outcome measure was endoscopic re-intervention within 6 months after stent placement. Secondary outcome measures were: improvement of dysphagia score at 1 week, 3 and 6 months, failed disintegration, increasing pain scores (visual analogue scale, 10 being worst possible pain) and complications. Patients' dysphagia score was listed weekly for the first month and thereafter monthly; their pain score was noted at day 1, 2 and 7. At 3 months a follow-up gastro-duodenoscopy was performed to investigate on stent disintegration and esophageal stricture. The total follow-up is 6 months.
Results: Between January 2009 and February 2010, 10 patients (8 men, 2 women; mean age ±standard deviation (SD) 62.1±6.8 years) were included. Nine patients had undergone esophagectomy because of esophageal carcinoma, one patient because of a Boerhaave's syndrome. Thus far 6 patients completed 6 months and 4 patients completed 4 months of follow-up. The dysphagia score improved significantly (Wilcoxon signed ranks test; p < 0.001) when comparing the mean score prior to stenting with the score at 1 week, 3 and if yet available 6 months. In all patients the stent disintegrated but was still partially visible at the 3 months endoscopy. Two patients suffered from pain (7 out of 10) directly after stent placement, the pain subsided completely within 1 week. Two patients (20%) required re-intervention because of reobstruction due to hyperplasia occurring 4 months after stent placement. No serious adverse events occurred.
Conclusions: Placement of the SX-ELLA biodegradable esophageal stent in patients with dysphagia due to benign anastomotic esophageal strictures appears to be safe and effective.