Steroid Versus Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture

NCT06626802 | Completed

• 1 other identifier: PedEsoStricture
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophageal Stricture

Keywords

Esophageal stricture; Mitomycin; Triamcinolone; Dysphagia

Outcome Measures

Primary Outcomes (1)

• Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS)

  Patients in both groups (group A and group B) will be followed and mean dysphagia severity score will be noted at 0, 2 and 6 weeks of intervention in both the groups. Improvement in dysphagia will be monitored via a validated Dysphagia Severity Score (DSS). It is as follows: 0 Able to eat normal diet/no dysphagia 1. Able to swallow some solid foods 2. Able to swallow only semi solid foods 3. Able to swallow liquids only 4. Unable to swallow anything/total dysphagia

  6 weeks

Study Arms (2)

Group A: Mitomycin

EXPERIMENTAL

Patients in Group A will be treated with esophageal dilation with a CRE balloon. After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. It will be applied in a dose of 1ml (0.4mg/ml); after dividing in to four aliquots, each aliquot will be applied to to one of the four quadrants.

Procedure: Balloon Dilation + Topical Mitomycin

Group B: Triamcinolone

EXPERIMENTAL

Patients in Group B will be treated with esophageal dilation with a CRE balloon. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Injection triamcinolone will be used in a dose of 1ml (40mg/ml). It will be divided in to four aliquots; each aliquot will be injected in to each of the four quadrants.

Procedure: Balloon Dilation + Injection Triamcinolone

Interventions

Balloon Dilation + Topical Mitomycin PROCEDURE

Patients with recurrent esophageal strictures in Group A will undergo endoscopy and balloon dilation with a CRE balloon, followed by injection Mitomycin applied topically at stricture site (post dilation)

Group A: Mitomycin

Balloon Dilation + Injection Triamcinolone PROCEDURE

Patients with recurrent esophageal strictures in Group B will undergo endoscopy and balloon dilation with a CRE balloon, followed by injection Triamcinolone, injected with a sclerotherapy injector, at stricture site (post dilation)

Group B: Triamcinolone

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Edward Medical University: lead
• Children Hospital and Institute of Child Health, Lahore: collaborator

Study Sites (1)

Children Hospital and University of Child Health Sciences Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (8)

• 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.

  PMID: 34868889 BACKGROUND

• Al Sarkhy AA, Saeed A, Hamid YH, Al Asmi MM, Altokhais TI, Ullah AA, Assiri AM. Efficacy and safety of endoscopic dilatation in the management of esophageal strictures in children. Saudi Med J. 2018 Aug;39(8):787-791. doi: 10.15537/smj.2018.8.22845.

  PMID: 30106416 BACKGROUND

• Boregowda U, Goyal H, Mann R, Gajendran M, Patel S, Echavarria J, Sayana H, Saligram S. Endoscopic management of benign recalcitrant esophageal strictures. Ann Gastroenterol. 2021;34(3):287-299. doi: 10.20524/aog.2021.0585. Epub 2021 Jan 27.

  PMID: 33948052 BACKGROUND

• Ravich WJ. Endoscopic Management of Benign Esophageal Strictures. Curr Gastroenterol Rep. 2017 Aug 24;19(10):50. doi: 10.1007/s11894-017-0591-8.

  PMID: 28840483 BACKGROUND

• 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.

  PMID: 36122370 BACKGROUND

• 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.

  PMID: 27846162 BACKGROUND

• 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.

  PMID: 32450581 BACKGROUND

• 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.

  PMID: 26455483 BACKGROUND

MeSH Terms

Conditions

Esophageal Stenosis; Deglutition Disorders

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tehreem Fatima, FCPS, MRCPCH

  University of Child Health Sciences, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 4, 2024
• Study Start: July 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)