Clinical trial NCT06626802: Steroid Versus Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture
Official title: Intralesional Steroid Injection Versus Topical Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Stricture
Keywords: Esophageal stricture
Mitomycin
Triamcinolone
Dysphagia
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
Collaborators: name: Children Hospital and Institute of Child Health, Lahore
First posted: 2024-10-04
Enrollment: 24
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of steroid injection versus topical mitomycin-C in the treatment of pediatric benign recurrent esophageal strictures. The rationale for this study is to compare the two therapeutic options in order to measure their effectiveness, in terms of improvement of Dysphagia Severity Score (DSS).

Detailed description: After taking approval from the Institutional Review Board of the university; and taking the informed consent from parents, patients fulfilling the inclusion and exclusion criteria will be enrolled in the study. They will be then randomly allocated into two groups; group A and group B. Patients in Group A will be treated with esophageal dilation with a CRE balloon (controlled radial expansion balloon). After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. Patients in Group B will be treated with esophageal dilation with a CRE balloon in the same manner. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Dysphagia Severity Score will be noted at start of intervention, at 2 weeks after intervention and at 6 weeks post- intervention.

Eligibility criteria: Inclusion Criteria:

* Patients up to 16 years of age belonging to both genders
* Patients with single esophageal stricture
* Patients with benign recurrent esophageal strictures
* Patients with any etiology for esophageal stricture including; post-corrosive, congenital, post-anastomotic and eosinophilic.

Exclusion Criteria:

* Patients unfit for anesthesia and/or hemodynamic instability
* Patients with hemostatic disorder (platelets \<50,000 or international normalized ratio \>1.5)
* Patients who have undergone esophageal surgery in last one month
* Patients with complications such as; stricture perforation, signs of air leak or mediastinitis
* Those with hypersensitivity to Mitomycin- C
* Patients with multiple strictures

Primary outcomes:
measure: Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Children Hospital and University of Child Health Sciences Lahore
state: Punjab
Study officials:
affiliation: University of Child Health Sciences, Lahore
name: Tehreem Fatima, FCPS, MRCPCH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarma MS, Tripathi PR, Arora S. Corrosive upper gastrointestinal strictures in children: Difficulties and dilemmas. World J Clin Pediatr. 2021 Nov 9;10(6):124-136. doi: 10.5409/wjcp.v10.i6.124. eCollection 2021 Nov 9.
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citation: Shahein AR, Krasaelap A, Ng K, Bitton S, Khan M, Manfredi MA, Lerner DG. Esophageal Dilation in Children: A State of the Art Review. J Pediatr Gastroenterol Nutr. 2023 Jan 1;76(1):1-8. doi: 10.1097/MPG.0000000000003614. Epub 2022 Sep 19.
citation: Divarci E, Celtik U, Dokumcu Z, Ozcan C, Erdener A. The Efficacy of Intralesional Steroid Injection in the Treatment of Corrosive Esophageal Strictures in Children. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):e122-e125. doi: 10.1097/SLE.0000000000000351.
citation: Dasari CS, Jegadeesan R, Patel HK, Desai M, Aziz M, Thoguluvachandrasekar V, Duvvuri A, Kohli DR, Repici A, Siersema PD, Sharma P. Intralesional steroids and endoscopic dilation for anastomotic strictures after esophagectomy: systematic review and meta-analysis. Endoscopy. 2020 Sep;52(9):721-726. doi: 10.1055/a-1172-5975. Epub 2020 May 25.
citation: Mendez-Nieto CM, Zarate-Mondragon F, Ramirez-Mayans J, Flores-Flores M. Topical mitomycin C versus intralesional triamcinolone in the management of esophageal stricture due to caustic ingestion. Rev Gastroenterol Mex. 2015 Oct-Dec;80(4):248-54. doi: 10.1016/j.rgmx.2015.07.006. Epub 2015 Oct 9. English, Spanish.