A new metal stent with a controlled-release system for palliation of malignant dysphagia: a prospective, multicenter study
Received 14 July 2009; accepted 25 September 2009. published online 09 December 2009.
Background
Self-expanding metal stents are frequently used for the palliation of malignant dysphagia. Recently, a new stent design, the Evolution stent (Cook Medical, Limerick, Ireland), was developed. The stent has an internal and external silicone coating to resist tissue ingrowth and uncoated dual flanges on both ends to prevent migration. Its controlled-release system may allow full control and precise positioning of the stent.
Objective
To determine the safety and clinical effectiveness of the Evolution stent for the palliation of dysphagia in patients with malignant strictures located in the esophagus (n = 33 [75%]) or gastric cardia (n = 11 [25%]).
Methods
All patients who underwent placement of an esophageal Evolution stent from February to December 2008 received follow-up telephone calls 14 days after treatment and thereafter monthly until death. Data on technical and clinical outcome, complications, and recurrent dysphagia were collected.
Results
A total of 44 patients (32 [73%] men, median age 74 years [range 48-91 years]) were treated with the Evolution stent. The median tumor length was 6 cm (range 1-11 cm). Stent placement was technically successful in 41 patients. Dysphagia improved from a median of 3 (ability to swallow liquids only) to 1 (ability to eat some solid foods) 4 weeks after stent placement. Major complications occurred in 4 (9%) patients, ie, pneumonia (3 patients) and hemorrhage (1 patient). Two (5%) patients died of pneumonia. Minor complications included gastroesophageal reflux and mild retrosternal pain in 11 (25%) and 4 (9%) patients, respectively. Recurrent dysphagia developed in 11 (25%) patients as a result of tissue ingrowth or overgrowth (6 patients; 14%), food impaction (3 patients; 7%), or stent migration (2 patients; 5%).
Conclusions
The Evolution stent is safe and effective for the palliation of dysphagia from esophageal and gastric cardia cancer. Randomized trials are needed to compare this device with other stent designs.
Utrecht, The Netherlands, Milan, Italy, Pisa, Italy
Current affiliations: Department of Gastroenterology and Hepatology (P.G.A.v.B., F.P.V., P.D.S.), University Medical Center Utrecht, Utrecht, The Netherlands, Department of Gastroenterology (A.R., G.R., C.C., N.P., A.M.), Istituto Clinico Humanitas, Milan, Italy, Department of Gastroenterology (B.S., M.R.), University Medical Center Pisa, Pisa, Italy
Reprint requests: Petra G.A. van Boeckel, MD, Department of Gastroenterology and Hepatology, Room F02.618, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.
DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: A. Repici: Grant support from Cook Ireland Ltd. P.D. Siersma: Grant support from Cook Ireland Ltd. The other authors disclosed no financial relationships relevant to this publication.
ABSTRACT