Ultraflex precision colonic stent placement as a bridge to surgery in patients with malignant colon obstruction.
BACKGROUND
Emergency surgery for malignant colon obstruction entails relatively high morbidity and mortality rates and typically necessitates a 2-step resection. These problems might be potentially mitigated by placement of a self-expanding metal stent (SEMS) as a bridge to surgery. A nitinol colorectal SEMS may offer several advantages, but available evidence on the utility of this SEMS type remains highly limited.


OBJECTIVE
Our purpose was to evaluate the effectiveness and safety as a bridge to surgery of a nitinol SEMS designed for colorectal use.


METHODS
Prospective and retrospective multicenter clinical study.


METHODS
Sixteen European study centers.


METHODS
Thirty-six patients with malignant colonic obstruction.


METHODS
Nitinol colorectal SEMS placement.


METHODS
Technical success in accurate SEMS placement with coverage of the entire stricture length, clinical success in alleviating colonic obstructive symptoms, and bridging to elective surgery.


RESULTS
Technical success was achieved in 97% of patients with a 95% CI of 85% to 100% and clinical success in 81% (95% CI, 64%-92%). Elective surgery was performed in 94% (95% CI, 81%-99%) of patients at a median of 11 days (95% CI, 7-15 days) after SEMS placement. SEMS-related perforation occurred in 3 patients.


CONCLUSIONS
No control group was included in this nonrandomized cohort study.


CONCLUSIONS
In this first comparatively large clinical study of a nitinol colorectal SEMS as a bridge to surgery, a high proportion of patients successfully proceeded to elective surgery after prior decompression by SEMS placement.
Fregonese
Diego
D
Camposampiero, Firenze, Rome, Prato, Torino, Milan, Italy, Valencia, Madrid, Burgos, Alicante, Palencia, Spain, Nice, Ajaccio, France, Copenhagen, Denmark.
Naspetti
Riccardo
R
Ferrer
Salvador
S
Gallego
Juan
J
Costamagna
Guido
G
Dumas
Remi
R
Campaioli
Marcello
M
Morante
Alfredo Lopez
AL
Mambrini
Pierre
P
Meisner
Søren
S
Repici
Alessandro
A
Andreo
Luis
L
Masci
Enzo
E
Mingo
Alberto
A
Barcenilla
Javier
J
Petruzziello
Lucio
L
D000230:Adenocarcinoma / Q000150:complications; D000328:Adult; D000497:Alloys; D003110:Colonic Neoplasms / Q000150:complications; D019299:Decompression, Surgical / Q000379:methods; D004378:Duodenal Diseases / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000209:etiology / Q000628:therapy*; D008297:Male; D011446:Prospective Studies; D011474:Prosthesis Design; D019919:Prosthesis Implantation; D012189:Retrospective Studies; D015607:Stents
D000497:Alloys; C013616:nitinol