Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial)
Introduction 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 the...
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BMJ Publishing Group
2019-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/12/e033030.full |
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| author | René M H Wijnen Hanneke IJsselstijn John Vlot Manon C W Spaander Joost van Rosmalen Erica L T van den Akker Marten J Poley Karel Allegaert Chantal A ten Kate |
| author_facet | René M H Wijnen Hanneke IJsselstijn John Vlot Manon C W Spaander Joost van Rosmalen Erica L T van den Akker Marten J Poley Karel Allegaert Chantal A ten Kate |
| author_sort | René M H Wijnen |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis 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—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 dissemination 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-2018–1586/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 numbers 2018-002863-24 and NTR7726/NL7484. |
| format | Article |
| id | doaj-art-1fac472e38464090bf952c813cb5cde2 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-1fac472e38464090bf952c813cb5cde22025-08-20T02:49:16ZengBMJ Publishing GroupBMJ Open2044-60552019-12-0191210.1136/bmjopen-2019-033030Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial)René M H Wijnen0Hanneke IJsselstijn1John Vlot2Manon C W Spaander3Joost van Rosmalen4Erica L T van den Akker5Marten J Poley6Karel Allegaert7Chantal A ten Kate84 Intensive Care and Department of Paediatric Surgery, Erasmus MC University Medical Center, Rotterdam, The NetherlandsDepartment of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children’s Hospital, Rotterdam, The NetherlandsDepartment of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children’s Hospital, Rotterdam, The NetherlandsDepartment of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands4 Biostatistics, Erasmus MC, Rotterdam, The Netherlands2 Department of Pediatric Endocrinology, Erasmus MC, University Medical Center, Rotterdam, The NetherlandsDepartment of Pediatric Surgery and Intensive Care, Erasmus MC, Rotterdam, The Netherlands4Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumDepartment of Paediatric Surgery and Intensive Care, Erasmus University Medical Center, Sophia Children’s Hospital, Rotterdam, The NetherlandsIntroduction 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.Methods and analysis 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—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 dissemination 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-2018–1586/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 numbers 2018-002863-24 and NTR7726/NL7484.https://bmjopen.bmj.com/content/9/12/e033030.full |
| spellingShingle | René M H Wijnen Hanneke IJsselstijn John Vlot Manon C W Spaander Joost van Rosmalen Erica L T van den Akker Marten J Poley Karel Allegaert Chantal A ten Kate Intralesional steroid injections to prevent refractory strictures in patients with oesophageal atresia: study protocol for an international, multicentre randomised controlled trial (STEPS-EA trial) BMJ Open |
| 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_full | 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_fullStr | 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_full_unstemmed | 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_short | 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_sort | 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://bmjopen.bmj.com/content/9/12/e033030.full |
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