A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video)

Kulwinder S. Dua, John DeWitt, William Kessler, David L. Diehl, Peter V. Draganov, Mihir S. Wagh, Michel Kahaleh, Louis M. Wong Kee Song, Harshit S. Khara, Abdul H. Khan, Murad M. Aburajab, Darren Ballard, Chris E. Forsmark, Steven A. Edmundowicz, Brian C. Brauer, Amy Tyberg, Najtej S. Buttar, Douglas G. Adler

Research output: Contribution to journalArticle

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Abstract

Background and Aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. Methods: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. Results: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ±.8; SEMS-V, 2.5 ±.8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [–17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P =.96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P =.61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P =.29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. Conclusions: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.)

Original languageEnglish (US)
JournalGastrointestinal Endoscopy
DOIs
StatePublished - Jan 1 2019

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Stents
Randomized Controlled Trials
Metals
Deglutition Disorders
Gastroesophageal Reflux
Quality of Life
Esophagogastric Junction
Aspiration Pneumonia

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

Cite this

A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video). / Dua, Kulwinder S.; DeWitt, John; Kessler, William; Diehl, David L.; Draganov, Peter V.; Wagh, Mihir S.; Kahaleh, Michel; Wong Kee Song, Louis M.; Khara, Harshit S.; Khan, Abdul H.; Aburajab, Murad M.; Ballard, Darren; Forsmark, Chris E.; Edmundowicz, Steven A.; Brauer, Brian C.; Tyberg, Amy; Buttar, Najtej S.; Adler, Douglas G.

In: Gastrointestinal Endoscopy, 01.01.2019.

Research output: Contribution to journalArticle

Dua, KS, DeWitt, J, Kessler, W, Diehl, DL, Draganov, PV, Wagh, MS, Kahaleh, M, Wong Kee Song, LM, Khara, HS, Khan, AH, Aburajab, MM, Ballard, D, Forsmark, CE, Edmundowicz, SA, Brauer, BC, Tyberg, A, Buttar, NS & Adler, DG 2019, 'A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video)', Gastrointestinal Endoscopy. https://doi.org/10.1016/j.gie.2019.01.013
Dua, Kulwinder S. ; DeWitt, John ; Kessler, William ; Diehl, David L. ; Draganov, Peter V. ; Wagh, Mihir S. ; Kahaleh, Michel ; Wong Kee Song, Louis M. ; Khara, Harshit S. ; Khan, Abdul H. ; Aburajab, Murad M. ; Ballard, Darren ; Forsmark, Chris E. ; Edmundowicz, Steven A. ; Brauer, Brian C. ; Tyberg, Amy ; Buttar, Najtej S. ; Adler, Douglas G. / A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video). In: Gastrointestinal Endoscopy. 2019.
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abstract = "Background and Aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. Methods: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. Results: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ±.8; SEMS-V, 2.5 ±.8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71{\%}; SEMS-V, 74{\%}; 95{\%} confidence interval, 1.93 [–17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P =.96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3{\%} in the SEMS-NV arm and 6.9{\%} in the SEMS-V arm (P =.61). Migration rates were similar (SEMS-NV, 33{\%}; SEMS-V, 48{\%}; P =.29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. Conclusions: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.)",
author = "Dua, {Kulwinder S.} and John DeWitt and William Kessler and Diehl, {David L.} and Draganov, {Peter V.} and Wagh, {Mihir S.} and Michel Kahaleh and {Wong Kee Song}, {Louis M.} and Khara, {Harshit S.} and Khan, {Abdul H.} and Aburajab, {Murad M.} and Darren Ballard and Forsmark, {Chris E.} and Edmundowicz, {Steven A.} and Brauer, {Brian C.} and Amy Tyberg and Buttar, {Najtej S.} and Adler, {Douglas G.}",
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TY - JOUR

T1 - A phase III, multicenter, prospective, single-blinded, noninferiority, randomized controlled trial on the performance of a novel esophageal stent with an antireflux valve (with video)

AU - Dua, Kulwinder S.

AU - DeWitt, John

AU - Kessler, William

AU - Diehl, David L.

AU - Draganov, Peter V.

AU - Wagh, Mihir S.

AU - Kahaleh, Michel

AU - Wong Kee Song, Louis M.

AU - Khara, Harshit S.

AU - Khan, Abdul H.

AU - Aburajab, Murad M.

AU - Ballard, Darren

AU - Forsmark, Chris E.

AU - Edmundowicz, Steven A.

AU - Brauer, Brian C.

AU - Tyberg, Amy

AU - Buttar, Najtej S.

AU - Adler, Douglas G.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background and Aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. Methods: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. Results: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ±.8; SEMS-V, 2.5 ±.8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [–17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P =.96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P =.61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P =.29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. Conclusions: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.)

AB - Background and Aims: Self-expanding metal stents (SEMSs) when deployed across the gastroesophageal junction (GEJ) can lead to reflux with risks of aspiration. A SEMS with a tricuspid antireflux valve (SEMS-V) was designed to address this issue. The aim of this study was to evaluate the efficacy and safety of this stent. Methods: A phase III, multicenter, prospective, noninferiority, randomized controlled trial was conducted on patients with malignant dysphagia requiring SEMSs to be placed across the GEJ. Patients were randomized to receive SEMSs with no valve (SEMS-NV) or SEMS-V. Postdeployment dysphagia score at 2 weeks and Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire score at 4 weeks were measured. Patients were followed for 24 weeks. Results: Sixty patients were randomized (SEMS-NV: 30 patients, mean age 67 ± 13 years; SEMS-V: 30 patients, mean age 65 ± 12 years). Baseline dysphagia scores (SEMS-NV, 2.5 ±.8; SEMS-V, 2.5 ±.8) and GERD-HRQL scores (SEMS-NV, 11.1 ± 8.2; SEMS-V, 12.8 ± 8.3) were similar. All SEMSs were successfully deployed. A similar proportion of patients in both arms improved from advanced dysphagia to moderate to no dysphagia (SEMS-NV, 71%; SEMS-V, 74%; 95% confidence interval, 1.93 [–17.8 to 21.7]). The dysphagia scores were also similar across all follow-up time points. Mean GERD-HRQL scores improved by 7.4 ± 10.2 points in the SEMS-V arm and by 5.2 ± 8.3 in the SEMS-NV group (P =.96). The GERD-HRQL scores were similar across all follow-up time points. Aspiration pneumonia occurred in 3.3% in the SEMS-NV arm and 6.9% in the SEMS-V arm (P =.61). Migration rates were similar (SEMS-NV, 33%; SEMS-V, 48%; P =.29). Two SEMS-V spontaneously fractured. There was no perforation, food impaction, or stent-related death in either group. Conclusions: The SEMS-V was equally effective in relieving dysphagia as compared with the SEMS-NV. Presence of the valve did not increase the risks of adverse events. GERD symptom scores were similar between the 2 stents, implying either that the valve was not effective or that all patients on proton pump inhibitors could have masked the symptoms of GERD. Studies with objective evaluations such as fluoroscopy and/or pH/impedance are recommended. (Clinical trial registration number: NCT02159898.)

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