Ultraflex precision colonic stent placement for palliation of malignant colonic obstruction: a prospective multicenter study

Gastrointest Endosc. 2007 Nov;66(5):920-7. doi: 10.1016/j.gie.2007.03.1042. Epub 2007 Sep 27.


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.

Design: Prospective multicenter clinical study.

Setting: Nine European study centers.

Patients: Forty-four patients with malignant colonic obstruction.

Interventions: Placement of nitinol SEMS designed for colorectal use.

Main outcome measures: 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.

Limitation: 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Alloys
  • Colon / surgery
  • Colonic Neoplasms / complications
  • Colonic Neoplasms / surgery
  • Female
  • Humans
  • Intestinal Obstruction / surgery*
  • Male
  • Palliative Care
  • Prospective Studies
  • Prosthesis Implantation / methods*
  • Stents*
  • Survival Rate


  • Alloys
  • nitinol