A new metal stent with a controlled-release system for palliation of malignant dysphagia: a prospective, multicenter study

P. G A van Boeckel, Alessandro Repici, Frank P. Vleggaar, Biagio Solito, Giacomo Rando, Claudio Cortelezzi, Mauro Rossi, Nico Pagano, Alberto Malesci, Peter D. Siersema

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)455-460
Number of pages6
JournalGastrointestinal Endoscopy
Volume71
Issue number3
DOIs
Publication statusPublished - Mar 2010

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Deglutition Disorders
Multicenter Studies
Stents
Metals
Prospective Studies
Cardia
Aptitude
Pneumonia
Food
Silicones
Deglutition
Gastroesophageal Reflux
Ireland
Telephone
Esophagus
Stomach Neoplasms
Stomach
Pathologic Constriction
Hemorrhage

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging

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A new metal stent with a controlled-release system for palliation of malignant dysphagia : a prospective, multicenter study. / van Boeckel, P. G A; Repici, Alessandro; Vleggaar, Frank P.; Solito, Biagio; Rando, Giacomo; Cortelezzi, Claudio; Rossi, Mauro; Pagano, Nico; Malesci, Alberto; Siersema, Peter D.

In: Gastrointestinal Endoscopy, Vol. 71, No. 3, 03.2010, p. 455-460.

Research output: Contribution to journalArticle

van Boeckel, PGA, Repici, A, Vleggaar, FP, Solito, B, Rando, G, Cortelezzi, C, Rossi, M, Pagano, N, Malesci, A & Siersema, PD 2010, 'A new metal stent with a controlled-release system for palliation of malignant dysphagia: a prospective, multicenter study', Gastrointestinal Endoscopy, vol. 71, no. 3, pp. 455-460. https://doi.org/10.1016/j.gie.2009.09.046
van Boeckel, P. G A ; Repici, Alessandro ; Vleggaar, Frank P. ; Solito, Biagio ; Rando, Giacomo ; Cortelezzi, Claudio ; Rossi, Mauro ; Pagano, Nico ; Malesci, Alberto ; Siersema, Peter D. / A new metal stent with a controlled-release system for palliation of malignant dysphagia : a prospective, multicenter study. In: Gastrointestinal Endoscopy. 2010 ; Vol. 71, No. 3. pp. 455-460.
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abstract = "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.",
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T2 - a prospective, multicenter study

AU - van Boeckel, P. G A

AU - Repici, Alessandro

AU - Vleggaar, Frank P.

AU - Solito, Biagio

AU - Rando, Giacomo

AU - Cortelezzi, Claudio

AU - Rossi, Mauro

AU - Pagano, Nico

AU - Malesci, Alberto

AU - Siersema, Peter D.

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N2 - 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.

AB - 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.

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