Letter to the Editor
Letter to the Editor: “Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: A prospective, randomized, controlled study”
Carta al editor: “Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: A prospective, randomized, controlled study”
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The study clearly has important methodological shortcomings that makes difficult to draw firm conclusions. Firstly, when a study of these characteristics is performed, the sample size calculation is critical. In this case, the sample size calculation was made aiming to find differences in the clinical success, but the expected outcomes are not specified. In addition, the primary outcome was not the clinical success but the technical success. A low number of patients were required (<span class="elsevierStyleItalic">n</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>28) but the total number of patients finally analyzed were only 12, clearly insufficient to demonstrate any differences. Secondly, during the study, the protocol was modified, and an EBD was performed prior to stent placement in 4 of 7 patients, being only 3 patients treated with stenting alone. This clearly affect the results of the SEMS treatment due to it is impossible to know what it was the responsible of the effects either for clinical and technical success and for adverse events. With these results it is impossible to make conclusions in any sense and less to say that patients with CD may benefit from treatment with SEMS rather than EBD. The overall success rate obtained in meta-analyses assessing the efficacy of EBD range from 58% to 80.8%.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">2</span></a> Regarding stent placement, the efficacy reported in the literature range from 51.3% to 58.7%,<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">3,4</span></a> with one of these studies being a randomized multicenter clinical trial designed by the authors of this letter comparing the use of stents versus EBD in the treatment of strictures of CD patients.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">4</span></a> The results of this clinical trial with 80 patients, showed that EBD is more effective (80.5% vs 51.3%) than fully covered SEMS with an equally good safety profile.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">4</span></a> Despite we appreciate the effort, value and the difficulty to carry out a study of these characteristics, this paper has a low quality that implies a confusing conclusion.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In summary, based on current literature, EBD should be the preferred endoscopic treatment for CD strictures.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Authors’ contribution</span><p id="par0015" class="elsevierStylePara elsevierViewall">CL wrote and critically reviewed the manuscript. XA and ME critically reviewed the manuscript.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Funding</span><p id="par0020" class="elsevierStylePara elsevierViewall">None for all authors.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Conflicts of interest</span><p id="par0025" class="elsevierStylePara elsevierViewall">None for all authors.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Authors’ contribution" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Funding" ] 2 => array:2 [ "identificador" => "sec0015" "titulo" => "Conflicts of interest" ] 3 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:4 [ 0 => array:3 [ "identificador" => "bib0025" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Endoscopic treatment of Crohn-related strictures with a self-expandable stent compared with balloon dilation: a prospective, randomised, controlled study" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "P. 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Van Assche" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1097/MIB.0000000000000988" "Revista" => array:6 [ "tituloSerie" => "Inflamm Bowel Dis" "fecha" => "2017" "volumen" => "23" "paginaInicial" => "133" "paginaFinal" => "142" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/28002130" "web" => "Medline" ] ] ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0035" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Therapeutic resolution of focal, predominantly anastomotic Crohn's disease strictures using removable stents: outcomes from a single-center case series in the United Kingdom" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "R. Das" 1 => "R. Singh" 2 => "S. Din" 3 => "J. Lund" 4 => "R. Krishnamoorthy" 5 => "S. 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Sicilia" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:2 [ "tituloSerie" => "Lancet Gastroenterol Hepatol" "fecha" => "2022" ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/02105705/0000004500000010/v1_202211220629/S0210570522000656/v1_202211220629/en/main.assets" "Apartado" => array:4 [ "identificador" => "9001" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Cartas al director" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/02105705/0000004500000010/v1_202211220629/S0210570522000656/v1_202211220629/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0210570522000656?idApp=UINPBA00004N" ]
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