Comparison of 2 expandable stents for malignant esophageal disease: a randomized controlled trial.

Background: Self-expanding metal stents (SEMSs) provide effective palliation in patients with malignant dysphagia. However, although life expectancy is generally limited, reintervention rates because of stent dysfunction are significant. New SEMSs are being designed to overcome this drawback.

Objectives: To investigate whether the results of SEMS placement could be improved with a new SEMS design.

Patients: Consecutive patients with dysphagia or leakage caused by malignant esophageal disease.

Methods: In a multicenter randomized clinical trial, consecutive patients with dysphagia or leakage because of malignant esophageal disease were randomized to placement of a conventional stent or the new stent. Patients were followed up by scheduled telephone calls 1 and 3 months after SEMS insertion.

Results: A total of 80 patients (73% male; median age, 67 years [range, 40-92 years]) were included. One patient refused follow-up. Technical success was 100% in both groups. The reintervention rate was 15/40 (38%) for the conventional stent and 4/39 (10%) for the new stent (P = .004). Major complications, including aspiration pneumonia and bleeding, occurred more frequently with the conventional stent (10/40, 25%) than with the new stent (3/39, 8%, P = .04). There was no difference in overall survival between the 2 groups.

Limitations: Inclusion of patients with a perforation or fistula.

Conclusions: The conventional stent and the new stent were equally effective in the relief of malignant dysphagia and sealing fistulae. The conventional stent was associated with more stent dysfunction and a significantly higher rate of major complications. Patients treated with the new stent also needed significantly fewer reinterventions than did those treated with a conventional stent. This sets the preference for the new stent over the conventional stent for patients with malignant esophageal disease.