To assess the effect of esophageal stent diameter on outcomes of patients with malignant esophageal obstruction.
Esophageal self-expandable metal stents (SEMS) effectively palliate dysphagia due to malignancy, but the best stent diameter is unknown.
A prospective randomized trial was conducted at a regional referral hospital. One hundred persons with unresectable esophageal cancer were enrolled, randomized to receive a SEMS of either 18 or 23 mm shaft diameter but identical design, and followed until death. Outcome measurements were dysphagia score, adverse events, endoscopic reintervention, and survival.
The study arms were evenly matched. Dysphagia resolved after stent placement in 95% in both groups. After 6 months the cumulative incidence of recurrent dysphagia was 38% (95% CI 18%-53%) versus 47% (26%-63%) in the small-diameter versus large-diameter groups, respectively (P=0.23). The cumulative incidence of adverse events was 57% in both groups at 6 months, with trends toward more frequent gastrointestinal bleeding and esophago-respiratory fistula in the large-diameter group, and more frequent stent migration, stent occlusion, and endoscopic reintervention in the small-diameter group. There was a trend toward longer survival in the small-diameter group (median survival, 5.9 vs. 3 mo; P=0.10). Higher initial performance status score and female gender were associated with improved survival. Limitations include enrollment of only 100 (of a planned 200) persons and incomplete follow-up of some participants.
Small-diameter and large-diameter esophageal SEMS provided similar palliation of dysphagia due to esophageal cancer. The overall incidence of adverse events was not affected by stent diameter, but there was a trend toward longer survival with small-diameter stents (Clinical trial registration number: NCT01894763).
Supplemental Digital Content is available in the text.
*Departments of Surgery and Internal Medicine, Tenwek Hospital, Bomet, Kenya
†Department of Biomedical Statistics and Informatics
‡Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website, www.jcge.com.
Stents used in this trial were provided free-of-charge by Boston Scientific Inc., Natick, MA.
R.E.W.: conception and design; analysis and interpretation of data; critical revision of article for important intellectual content; final approval of the article. R.C.: conception and design; analysis and interpretation of data; final approval of the article. M.M.: analysis and interpretation of data; final approval of the article. S.L.B. and F.T.E.: analysis and interpretation of data; critical revision of article for important intellectual content; final approval of the article. M.T.: conception and design; analysis and interpretation of data; drafting of the article; critical revision of article for important intellectual content; final approval of the article.
The authors declare that they have nothing to disclose.
Reprints: Mark Topazian, MD, Mayo Clinic, 200 First St., Rochester, MN 55906 (e-mail: firstname.lastname@example.org) and Russell E. White, MD, Tenwek Hospital, P.O. Box 39, Bomet, Kenya 20400 (e-mail: email@example.com).
Received August 4, 2014
Accepted March 23, 2015