Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial)
IntroductionAnastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and ther...
Gespeichert in:
| Veröffentlicht in: | BMJ open 2019-12, Vol.9 (12), p.e033030-e033030 |
|---|---|
| Hauptverfasser: | , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | e033030 |
|---|---|
| container_issue | 12 |
| container_start_page | e033030 |
| container_title | BMJ open |
| container_volume | 9 |
| creator | ten Kate, Chantal A Vlot, John IJsselstijn, Hanneke Allegaert, Karel Spaander, Manon C W Poley, Marten J van Rosmalen, Joost van den Akker, Erica L T Wijnen, Rene M H |
| description | IntroductionAnastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children.Methods and analysisThis is an international multicentre randomised controlled trial. Children with OA type C (n=110) will be randomised into intralesional steroid injection followed by balloon dilatation or dilatation only. Randomisation and intervention will take place when a third dilatation is performed. The indication for dilatation will be confirmed with an oesophagram. One radiologist—blinded for randomisation—will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with |
| doi_str_mv | 10.1136/bmjopen-2019-033030 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6937109</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2328343055</sourcerecordid><originalsourceid>FETCH-LOGICAL-b472t-d7ee979103411f3d809652982e52d659cab4ea9567179ae4672ed0aad2e38ca33</originalsourceid><addsrcrecordid>eNqNkl1rFDEUhgdRbKn9BYIEvKnQqfmYr3hRKGWrhYJC63U4O3O2myUzGZNMZX-g_8uznbVUr5ybfMzzvifJebPsreBnQqjq47Lf-BGHXHKhc64UV_xFdih5UeQVL8uXz-YH2XGMG05fUeqylK-zAyWaohG1PMx-XQ8pgMNo_QCOxYTB247ZYYNtor3IkmdjwAccEgu4CtAmH7YEBtumKWAklo2QLAGR_bRpzTxGP67hHskQEiEWPpFg6rbk5JNvvWMrHxgMpKWCA6TH6qesn1yyLTkFZAGGzvc2YsdaTzveOZpSWXI9ub1bfLvNFxfz-sOb7NUKXMTj_XiUfb9a3F1-yW--fr6-vLjJl0UtU97ViLrWgqtCiJXqGq6rUupGYim7qtQtLAsEXVa1qDVgUdUSOw7QSVRNC0odZeez7zgte-weTwrOjMH2ELbGgzV__xns2tz7B1NpVQuuyeBkbxD8jwljMnTDFp2DAf0UjVSyUYWirhH6_h904yd6K7ejiroSDXWRKDVTbfAxUoOeDiO42SXF7JNidkkxc1JI9e75PZ40f3JBwNkMkPq_HH8Daa7QOg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2347618318</pqid></control><display><type>article</type><title>Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial)</title><source>BMJ Open Access Journals</source><source>DOAJ Directory of Open Access Journals</source><source>PubMed Central Open Access</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>ten Kate, Chantal A ; Vlot, John ; IJsselstijn, Hanneke ; Allegaert, Karel ; Spaander, Manon C W ; Poley, Marten J ; van Rosmalen, Joost ; van den Akker, Erica L T ; Wijnen, Rene M H</creator><creatorcontrib>ten Kate, Chantal A ; Vlot, John ; IJsselstijn, Hanneke ; Allegaert, Karel ; Spaander, Manon C W ; Poley, Marten J ; van Rosmalen, Joost ; van den Akker, Erica L T ; Wijnen, Rene M H</creatorcontrib><description>IntroductionAnastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children.Methods and analysisThis is an international multicentre randomised controlled trial. Children with OA type C (n=110) will be randomised into intralesional steroid injection followed by balloon dilatation or dilatation only. Randomisation and intervention will take place when a third dilatation is performed. The indication for dilatation will be confirmed with an oesophagram. One radiologist—blinded for randomisation—will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with <28 days’ interval, which will be analysed with a linear-by-linear χ2 association test. Secondary outcome parameters include the level of dysphagia, the luminal oesophageal diameter and stricture length (measured on the oesophagrams), the influence of comedication on stricture formation, systemic effects of intralesional steroids (cortisol levels, length and weight) and the cost-effectiveness. Patients will undergo a second oesophagram; length and weight will be measured repeatedly; a scalp hair sample will be collected; and three questionnaires will be administered. The follow-up period will be 6 months, with evaluation at 2–3 weeks, 3 and 6 months after the intervention.Ethics and disseminationPatients will be included after written parental informed consent. The risks and burden associated with this trial are minimal. The institutional review board of the Erasmus Medical Centre approved this protocol (MEC-2018–1586/NL65364.078.18). The results of the trial will be published in a peer-reviewed scientific journal and will be presented at international conferences.Trial registration numbers2018-002863-24 and NTR7726/NL7484.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2019-033030</identifier><identifier>PMID: 31848172</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adults ; Age ; Collagen ; Congenital diseases ; Cost analysis ; Dysphagia ; Endoscopy ; Esophagus ; Fistula ; Patients ; Surgery</subject><ispartof>BMJ open, 2019-12, Vol.9 (12), p.e033030-e033030</ispartof><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.</rights><rights>2019 Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. 2019</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-d7ee979103411f3d809652982e52d659cab4ea9567179ae4672ed0aad2e38ca33</citedby><cites>FETCH-LOGICAL-b472t-d7ee979103411f3d809652982e52d659cab4ea9567179ae4672ed0aad2e38ca33</cites><orcidid>0000-0001-9921-7776</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/9/12/e033030.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/9/12/e033030.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,315,729,782,786,866,887,27556,27557,27931,27932,53798,53800,77609,77640</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31848172$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>ten Kate, Chantal A</creatorcontrib><creatorcontrib>Vlot, John</creatorcontrib><creatorcontrib>IJsselstijn, Hanneke</creatorcontrib><creatorcontrib>Allegaert, Karel</creatorcontrib><creatorcontrib>Spaander, Manon C W</creatorcontrib><creatorcontrib>Poley, Marten J</creatorcontrib><creatorcontrib>van Rosmalen, Joost</creatorcontrib><creatorcontrib>van den Akker, Erica L T</creatorcontrib><creatorcontrib>Wijnen, Rene M H</creatorcontrib><title>Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial)</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionAnastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children.Methods and analysisThis is an international multicentre randomised controlled trial. Children with OA type C (n=110) will be randomised into intralesional steroid injection followed by balloon dilatation or dilatation only. Randomisation and intervention will take place when a third dilatation is performed. The indication for dilatation will be confirmed with an oesophagram. One radiologist—blinded for randomisation—will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with <28 days’ interval, which will be analysed with a linear-by-linear χ2 association test. Secondary outcome parameters include the level of dysphagia, the luminal oesophageal diameter and stricture length (measured on the oesophagrams), the influence of comedication on stricture formation, systemic effects of intralesional steroids (cortisol levels, length and weight) and the cost-effectiveness. Patients will undergo a second oesophagram; length and weight will be measured repeatedly; a scalp hair sample will be collected; and three questionnaires will be administered. The follow-up period will be 6 months, with evaluation at 2–3 weeks, 3 and 6 months after the intervention.Ethics and disseminationPatients will be included after written parental informed consent. The risks and burden associated with this trial are minimal. The institutional review board of the Erasmus Medical Centre approved this protocol (MEC-2018–1586/NL65364.078.18). The results of the trial will be published in a peer-reviewed scientific journal and will be presented at international conferences.Trial registration numbers2018-002863-24 and NTR7726/NL7484.</description><subject>Adults</subject><subject>Age</subject><subject>Collagen</subject><subject>Congenital diseases</subject><subject>Cost analysis</subject><subject>Dysphagia</subject><subject>Endoscopy</subject><subject>Esophagus</subject><subject>Fistula</subject><subject>Patients</subject><subject>Surgery</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkl1rFDEUhgdRbKn9BYIEvKnQqfmYr3hRKGWrhYJC63U4O3O2myUzGZNMZX-g_8uznbVUr5ybfMzzvifJebPsreBnQqjq47Lf-BGHXHKhc64UV_xFdih5UeQVL8uXz-YH2XGMG05fUeqylK-zAyWaohG1PMx-XQ8pgMNo_QCOxYTB247ZYYNtor3IkmdjwAccEgu4CtAmH7YEBtumKWAklo2QLAGR_bRpzTxGP67hHskQEiEWPpFg6rbk5JNvvWMrHxgMpKWCA6TH6qesn1yyLTkFZAGGzvc2YsdaTzveOZpSWXI9ub1bfLvNFxfz-sOb7NUKXMTj_XiUfb9a3F1-yW--fr6-vLjJl0UtU97ViLrWgqtCiJXqGq6rUupGYim7qtQtLAsEXVa1qDVgUdUSOw7QSVRNC0odZeez7zgte-weTwrOjMH2ELbGgzV__xns2tz7B1NpVQuuyeBkbxD8jwljMnTDFp2DAf0UjVSyUYWirhH6_h904yd6K7ejiroSDXWRKDVTbfAxUoOeDiO42SXF7JNidkkxc1JI9e75PZ40f3JBwNkMkPq_HH8Daa7QOg</recordid><startdate>20191216</startdate><enddate>20191216</enddate><creator>ten Kate, Chantal A</creator><creator>Vlot, John</creator><creator>IJsselstijn, Hanneke</creator><creator>Allegaert, Karel</creator><creator>Spaander, Manon C W</creator><creator>Poley, Marten J</creator><creator>van Rosmalen, Joost</creator><creator>van den Akker, Erica L T</creator><creator>Wijnen, Rene M H</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-9921-7776</orcidid></search><sort><creationdate>20191216</creationdate><title>Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial)</title><author>ten Kate, Chantal A ; Vlot, John ; IJsselstijn, Hanneke ; Allegaert, Karel ; Spaander, Manon C W ; Poley, Marten J ; van Rosmalen, Joost ; van den Akker, Erica L T ; Wijnen, Rene M H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-d7ee979103411f3d809652982e52d659cab4ea9567179ae4672ed0aad2e38ca33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adults</topic><topic>Age</topic><topic>Collagen</topic><topic>Congenital diseases</topic><topic>Cost analysis</topic><topic>Dysphagia</topic><topic>Endoscopy</topic><topic>Esophagus</topic><topic>Fistula</topic><topic>Patients</topic><topic>Surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>ten Kate, Chantal A</creatorcontrib><creatorcontrib>Vlot, John</creatorcontrib><creatorcontrib>IJsselstijn, Hanneke</creatorcontrib><creatorcontrib>Allegaert, Karel</creatorcontrib><creatorcontrib>Spaander, Manon C W</creatorcontrib><creatorcontrib>Poley, Marten J</creatorcontrib><creatorcontrib>van Rosmalen, Joost</creatorcontrib><creatorcontrib>van den Akker, Erica L T</creatorcontrib><creatorcontrib>Wijnen, Rene M H</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>ten Kate, Chantal A</au><au>Vlot, John</au><au>IJsselstijn, Hanneke</au><au>Allegaert, Karel</au><au>Spaander, Manon C W</au><au>Poley, Marten J</au><au>van Rosmalen, Joost</au><au>van den Akker, Erica L T</au><au>Wijnen, Rene M H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial)</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2019-12-16</date><risdate>2019</risdate><volume>9</volume><issue>12</issue><spage>e033030</spage><epage>e033030</epage><pages>e033030-e033030</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionAnastomotic stricture formation is the most common postoperative complication after oesophageal atresia (OA) repair. The standard of care is endoscopic dilatation. A possible adjuvant treatment is intralesional steroid injection, which is thought to inhibit scar tissue formation and thereby to prevent stricture recurrence. We hypothesise that this intervention could prevent refractory strictures and reduce the total number of dilatations needed in these children.Methods and analysisThis is an international multicentre randomised controlled trial. Children with OA type C (n=110) will be randomised into intralesional steroid injection followed by balloon dilatation or dilatation only. Randomisation and intervention will take place when a third dilatation is performed. The indication for dilatation will be confirmed with an oesophagram. One radiologist—blinded for randomisation—will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with <28 days’ interval, which will be analysed with a linear-by-linear χ2 association test. Secondary outcome parameters include the level of dysphagia, the luminal oesophageal diameter and stricture length (measured on the oesophagrams), the influence of comedication on stricture formation, systemic effects of intralesional steroids (cortisol levels, length and weight) and the cost-effectiveness. Patients will undergo a second oesophagram; length and weight will be measured repeatedly; a scalp hair sample will be collected; and three questionnaires will be administered. The follow-up period will be 6 months, with evaluation at 2–3 weeks, 3 and 6 months after the intervention.Ethics and disseminationPatients will be included after written parental informed consent. The risks and burden associated with this trial are minimal. The institutional review board of the Erasmus Medical Centre approved this protocol (MEC-2018–1586/NL65364.078.18). The results of the trial will be published in a peer-reviewed scientific journal and will be presented at international conferences.Trial registration numbers2018-002863-24 and NTR7726/NL7484.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>31848172</pmid><doi>10.1136/bmjopen-2019-033030</doi><orcidid>https://orcid.org/0000-0001-9921-7776</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 2044-6055 |
| ispartof | BMJ open, 2019-12, Vol.9 (12), p.e033030-e033030 |
| issn | 2044-6055 2044-6055 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6937109 |
| source | BMJ Open Access Journals; DOAJ Directory of Open Access Journals; PubMed Central Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Adults Age Collagen Congenital diseases Cost analysis Dysphagia Endoscopy Esophagus Fistula Patients Surgery |
| title | Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial) |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-04T14%3A58%3A08IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Intralesional%20steroid%20injections%20to%20prevent%20refractory%20strictures%20in%20patients%20with%20oesophageal%20atresia:%20study%20protocol%20for%20an%20international,%20multicentre%20randomised%20controlled%20trial%20(STEPS-EA%20trial)&rft.jtitle=BMJ%20open&rft.au=ten%20Kate,%20Chantal%20A&rft.date=2019-12-16&rft.volume=9&rft.issue=12&rft.spage=e033030&rft.epage=e033030&rft.pages=e033030-e033030&rft.issn=2044-6055&rft.eissn=2044-6055&rft_id=info:doi/10.1136/bmjopen-2019-033030&rft_dat=%3Cproquest_pubme%3E2328343055%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2347618318&rft_id=info:pmid/31848172&rfr_iscdi=true |