Randomized trial of small-diameter versus large-diameter esophageal stents for palliation of malignant esophageal obstruction

Russell E. White, Robert Chepkwony, Michael Mwachiro, Stephen L. Burgert, Felicity T Enders, Mark Topazian

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Goals: To assess the effect of esophageal stent diameter on outcomes of patients with malignant esophageal obstruction. Background: Esophageal self-expandable metal stents (SEMS) effectively palliate dysphagia due to malignancy, but the best stent diameter is unknown. Study: 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 23mm shaft diameter but identical design, and followed until death. Outcome measurements were dysphagia score, adverse events, endoscopic reintervention, and survival. Results: 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. Conclusions: 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 smalldiameter stents (Clinical trial registration number: NCT01894763).

Original languageEnglish (US)
Pages (from-to)660-665
Number of pages6
JournalJournal of Clinical Gastroenterology
Volume49
Issue number8
StatePublished - 2015

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Stents
Deglutition Disorders
Survival
Esophageal Neoplasms
Incidence
Fistula
Referral and Consultation
Clinical Trials
Prospective Studies
Hemorrhage
Self Expandable Metallic Stents
Neoplasms

Keywords

  • Adverse effects
  • Dysphagia
  • Esophageal neoplasms
  • Randomized controlled trial
  • Stents

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Randomized trial of small-diameter versus large-diameter esophageal stents for palliation of malignant esophageal obstruction. / White, Russell E.; Chepkwony, Robert; Mwachiro, Michael; Burgert, Stephen L.; Enders, Felicity T; Topazian, Mark.

In: Journal of Clinical Gastroenterology, Vol. 49, No. 8, 2015, p. 660-665.

Research output: Contribution to journalArticle

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abstract = "Goals: To assess the effect of esophageal stent diameter on outcomes of patients with malignant esophageal obstruction. Background: Esophageal self-expandable metal stents (SEMS) effectively palliate dysphagia due to malignancy, but the best stent diameter is unknown. Study: 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 23mm shaft diameter but identical design, and followed until death. Outcome measurements were dysphagia score, adverse events, endoscopic reintervention, and survival. Results: 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. Conclusions: 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 smalldiameter stents (Clinical trial registration number: NCT01894763).",
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AU - White, Russell E.

AU - Chepkwony, Robert

AU - Mwachiro, Michael

AU - Burgert, Stephen L.

AU - Enders, Felicity T

AU - Topazian, Mark

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N2 - Goals: To assess the effect of esophageal stent diameter on outcomes of patients with malignant esophageal obstruction. Background: Esophageal self-expandable metal stents (SEMS) effectively palliate dysphagia due to malignancy, but the best stent diameter is unknown. Study: 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 23mm shaft diameter but identical design, and followed until death. Outcome measurements were dysphagia score, adverse events, endoscopic reintervention, and survival. Results: 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. Conclusions: 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 smalldiameter stents (Clinical trial registration number: NCT01894763).

AB - Goals: To assess the effect of esophageal stent diameter on outcomes of patients with malignant esophageal obstruction. Background: Esophageal self-expandable metal stents (SEMS) effectively palliate dysphagia due to malignancy, but the best stent diameter is unknown. Study: 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 23mm shaft diameter but identical design, and followed until death. Outcome measurements were dysphagia score, adverse events, endoscopic reintervention, and survival. Results: 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. Conclusions: 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 smalldiameter stents (Clinical trial registration number: NCT01894763).

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