{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,21]],"date-time":"2026-05-21T09:40:43Z","timestamp":1779356443694,"version":"3.51.4"},"reference-count":36,"publisher":"BMJ","issue":"12","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,11,27]]},"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Anastomotic 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This 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\u2014blinded for randomisation\u2014will review all oesophagrams. The primary outcome parameter is the total number of dilatations needed with &lt;28 days\u2019 interval, which will be analysed with a linear-by-linear \u03c7\n                      <jats:sup>2<\/jats:sup>\n                      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\u2009months, with evaluation at 2\u20133 weeks, 3 and 6 months after the intervention.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Patients 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\u20131586\/NL65364.078.18). The results of the trial will be published in a peer-reviewed scientific journal and will be presented at international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration numbers<\/jats:title>\n                    <jats:p>2018-002863-24 and NTR7726\/NL7484.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-033030","type":"journal-article","created":{"date-parts":[[2019,12,17]],"date-time":"2019-12-17T04:05:16Z","timestamp":1576555516000},"page":"e033030","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"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)"],"prefix":"10.1136","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9921-7776","authenticated-orcid":false,"given":"Chantal A","family":"ten Kate","sequence":"first","affiliation":[{"name":"Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children\u2019s Hospital, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Vlot","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children\u2019s Hospital, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hanneke","family":"IJsselstijn","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children\u2019s Hospital, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karel","family":"Allegaert","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Division of Neonatology, Erasmus University Medical Center, Sophia Children\u2019s Hospital, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manon C W","family":"Spaander","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marten J","family":"Poley","sequence":"additional","affiliation":[{"name":"Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joost","family":"van Rosmalen","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Erasmus University Medical 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