The new multi-diameter Controlled Radial Expansion (CRE™) Balloon (Mkrovasive®, Boston Scientific Corp., Natick USA) expands to 3 distinct, increasing diameters by progressively increasing its hydrostatic pressure from 3 to 5 to 7 atm using the Alliance™ inflation-deflation device. Linear correlation has been observed between the 3 balloon diameters and the increasing hydrostatic pressure. The purpose of this study was to report preliminary, clinical results using the CRE™ balloon. METHODS: Nine patients with benign esophageal strictures underwent CRE™ balloon dilatation. The stenoses varied from 5-13mm in diameter (median=IImm). Dysphagia was graded on a 0-5 scale (5 being normal) with the groups median score of 3 (range: 1-4). The patients underwent endoscopy with conscious sedation, using standard gastroscopes and CRE™ balloon dilation was performed. Balloon dilation was monitored by fluoroscopy for presence of a waist. RESULTS: The balloons were easy to pass through the instrument channels, and expanded without waisting within the strictures. Three patients underwent stepwise dilatation utilizing 2 catheters with sizes of 12mm-13.5mm-15mm, followed by 15mm-16.5mm-18mm, and 9 patients underwent dilation with one catheter using the 15mm-16.5mm-18mm dilator. Inflation time at each diameter ranged from 30 sec. to 120 sec. Median total inflation time was 240 sec. (range: 150-360 sec.) Dilatation was performed up to 18mm in all cases except one which was dilated to 16.5mm. The dilatation was successful in all patients and no immediate complications occurred. All patients had clinical improvement in dysphagia score of at least I grade. CONCLUSIONS: The CRE™ balloon easily and efficiently dilated to 3 diameters without waisting within the stricture and easily passed through the scope (TTS), successfully accomplishing stricture dilation. The CRE™ balloon may represent major progress in TTS technique.
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging