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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) - 20/06/19

Doi : 10.1016/j.gie.2019.01.013 
Kulwinder S. Dua, MD, FASGE, FACP, FRCP 1, ⁎, John M. DeWitt, MD 2, William R. Kessler, MD 2, David L. Diehl, MD 3, Peter V. Draganov, MD 4, Mihir S. Wagh, MD 5, Michel Kahaleh, MD 6, Louis M. Wong Kee Song, MD 7, Harshit S. Khara, MD 3, Abdul H. Khan, MD 1, Murad M. Aburajab, MD 1, Darren Ballard, MD 1, Chris E. Forsmark, MD 4, Steven A. Edmundowicz, MD 5, Brian C. Brauer, MD 5, Amy Tyberg, MD 6, Najtej S. Buttar, MD 7, Douglas G. Adler, MD 8
1 Department of Medicine, Division of Gastroenterology and Hepatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA 
2 Department of Medicine, Division of Gastroenterology and Hepatology, Indiana University Hospital, Indianapolis, Indiana, USA 
3 Department of Medicine, Division of Gastroenterology and Hepatology, Geisinger Medical Center, Danville, Pennsylvania, USA 
4 Department of Medicine, Division of Gastroenterology and Hepatology, University of Florida, Gainesville, Florida, USA 
5 Department of Medicine, Division of Gastroenterology and Hepatology, University of Colorado Denver, Aurora, Colorado, USA 
6 Department of Medicine, Division of Gastroenterology and Hepatology, Robert Wood Johnson University Hospital, New Brunswick, New Jersey, USA 
7 Department of Medicine, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA 
8 Department of Medicine, Division of Gastroenterology and Hepatology, University of Utah School of Medicine, Salt Lake City, Utah, USA 

∗Reprint requests: Kulwinder S. Dua, MD, FRCP(L), FRCP(E), FACP, FASGE, Professor of Medicine and Pediatrics, Medical College of Wisconsin, Division of Gastroenterology and Hepatology, 9200 W Wisconsin Ave, Milwaukee, WI 53226.Professor of Medicine and PediatricsMedical College of WisconsinDivision of Gastroenterology and Hepatology9200 W Wisconsin AveMilwaukeeWI53226

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.)

Le texte complet de cet article est disponible en PDF.

Graphical abstract




Le texte complet de cet article est disponible en PDF.

Abbreviations : AE, FDA, GEJ, GER, GERD-HRQL, ITT, LOCF, PPI, SEMS, SEMS-NV, SEMS-V


Plan


 DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: K. S. Dua: Grant recipient from Boston Scientific,Cook Medical, and Merit Medical; speaker for Boston Scientific. J. M. DeWitt: Consultant for Olympus America, Boston Scientific, and Pinnacle Biologics. W. R. Kessler, P. V. Draganov: Grant recipient from Merit Medical, consultant for Cook, BSC, Olympus, Microteck, and MicroTech; Merit and paid speaker for Cook, BSC, and Olympus. D. L. Diehl: Consultant for Merit Medical. M. S. Wagh: Consultant for Boston Scientific and Medtronic. M. Kahaleh: Grant recipient from Merit Medical, Olympus America, Boston Scientific, Cook Medical, Aspire Bariatrics, GI Dynamics, Apollo, Fuji, Pentax, Emcision, Concordia, MI Tech, Maunakea Tech, Ninepoint Medical, and W.L. Gore. S. A. Edmundowicz: Medical advisory board member for Endostim, Check-Cap, Motus GI, Elira, and Olympus; stock options from Endostim, Check-Cap, Motus GI, and Freehold Surgical; stockholder for Elira (also spouse), Aspero Medical Inc, UV Concepts Incorporated (spouse), and Motus GI (spouse); consultant for Motus GI, Olympus, Medtronic, and Allurion; co-founder of Aspero Medical Inc; paid associate editor for Elsevier; Data Safety Monitoring Board Chair for Allurion. B. C. Brauer: Consultant for Boston Scientific and Medtronic; grant recipient from Erbe. D. G. Adler: Consultant for Boston Scientific and Merit Medical. L.M. Wong Kee Song: grant from Merit Medical. All other authors disclosed no financial relationships relevant to this publication. Research support for this study was provided by Merit Medical.
 See CME section; p. 150.
 If you would like to chat with an author of this article, you may contact Dr Dua at kdua@mcw.edu.


© 2019  American Society for Gastrointestinal Endoscopy. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 90 - N° 1

P. 64 - juillet 2019 Retour au numéro
Article précédent Article précédent
  • Quality assurance of computer-aided detection and diagnosis in colonoscopy
  • Daniela Guerrero Vinsard, Yuichi Mori, Masashi Misawa, Shin-ei Kudo, Amit Rastogi, Ulas Bagci, Douglas K. Rex, Michael B. Wallace
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  • Antireflux esophageal stents: Do we have a winner?
  • Isaac Raijman

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