Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction: a prospective multicenter study.
BACKGROUND
Many patients who develop obstructive colonic symptoms secondary to inoperable colorectal cancer will require palliative treatment. A minimally invasive and potentially long-lasting approach is placement of nitinol self-expanding metal stents (SEMS).


OBJECTIVE
To determine the effectiveness and safety of a nitinol SEMS designed for colorectal use in the palliative treatment of malignant colonic obstruction.


METHODS
Prospective multicenter clinical study.


METHODS
Nine European study centers.


METHODS
Forty-four patients with malignant colonic obstruction.


METHODS
Placement of nitinol SEMS designed for colorectal use.


METHODS
Technical success, defined as accurate SEMS deployment with adequate stricture coverage, and clinical success, defined as decompression and relief of obstructive colonic symptoms maintained without intervention or serious device-related complications.


RESULTS
Technical success was attained in 95% of patients, with 95% CI 85%-99%. After 6 months, the rate of clinical success was 81%, 95% CI 69%-96%. Survival at 6 months was 67%, 95% CI 54%-84%. Clinical success was maintained until death in 86% of the nonsurvivors. No perforations or SEMS-related deaths occurred.


CONCLUSIONS
This investigation was nonrandomized and did not include a control group.


CONCLUSIONS
In a large prospective investigation, palliative placement of a nitinol SEMS designed for colorectal use was accomplished with a high rate of technical success. Durable clinical success was achieved in a high proportion of patients with low morbidity.
Repici
Alessandro
A
Servizio di Endoscopia Digestiva, IRCCS Istituto Clinico Humanitas, Milano, Italy.
Fregonese
Diego
D
Costamagna
Guido
G
Dumas
Remi
R
Kähler
Georg
G
Meisner
Søren
S
Giovannini
Marc
M
Freeman
Jan
J
Petruziello
Lucio
L
Hervoso
Cristina
C
Comunale
Salvatore
S
Faroux
Roger
R
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D003106:Colon / Q000601:surgery; D003110:Colonic Neoplasms / Q000150:complications / Q000601:surgery; D005260:Female; D006801:Humans; D007415:Intestinal Obstruction / Q000601:surgery*; D008297:Male; D010166:Palliative Care; D011446:Prospective Studies; D019919:Prosthesis Implantation / Q000379:methods*; D015607:Stents; D015996:Survival Rate
D000497:Alloys; C013616:nitinol