The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children

NCT04524897 | Unknown Phase 4

• 1 other identifier: TIRBESC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy of Intra-lesional triamcinolone injection in the management of refractory benign esophageal Stricture in children.

Conditions

Esophageal Stricture

Keywords

triamcinolole; refractory esophageal stricture; children

Outcome Measures

Primary Outcomes (1)

• number of patients show improvement in dysphagia scale after five session of triamcinolone injection

  number of patients show improvement in dysphagia scale after five session of triamcinolone injection

  2years

Secondary Outcomes (1)

• the number of patients who will show complete relieve of dysphagia after five sessions of triamcinolone injection

  2years

Study Arms (1)

The use of Triamcinolone Injection

OTHER

Triamcinolone acetate (40 mg/mL)

Drug: Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children

Interventions

Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children DRUG

Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation

Also known as: Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation

The use of Triamcinolone Injection

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All patients admitted to Assiut University Children Hospital with:
• refractory benign esophageal stricture(inability to successfully remediate the anatomic problem to a diameter of at least 14 mm over five sessions at two-week interval)
• inability to maintain a satisfactory luminal diameter for four weeks once the target diameter of 14 mm has been achieved

You may not qualify if:

• Pharyngeal stenosis precluding endoscopic examination and dilatation
• tracheo-esophageal fistula,
• gastric cicatrization that precluded safe placement of aguidewire
• any patient who was unfit for general anesthesia.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• Morikawa N, Honna T, Kuroda T, Watanabe K, Tanaka H, Takayasu H, Fujino A, Tanemura H, Matsukubo M. High dose intravenous methylprednisolone resolves esophageal stricture resistant to balloon dilatation with intralesional injection of dexamethasone. Pediatr Surg Int. 2008 Oct;24(10):1161-4. doi: 10.1007/s00383-008-2224-7.

  PMID: 18704454 BACKGROUND

• Contini S, Scarpignato C. Caustic injury of the upper gastrointestinal tract: a comprehensive review. World J Gastroenterol. 2013 Jul 7;19(25):3918-30. doi: 10.3748/wjg.v19.i25.3918.

  PMID: 23840136 BACKGROUND

• Mowry JB, Spyker DA, Cantilena LR Jr, McMillan N, Ford M. 2013 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 31st Annual Report. Clin Toxicol (Phila). 2014 Dec;52(10):1032-283. doi: 10.3109/15563650.2014.987397.

  PMID: 25559822 BACKGROUND

• Park KS. Evaluation and management of caustic injuries from ingestion of Acid or alkaline substances. Clin Endosc. 2014 Jul;47(4):301-7. doi: 10.5946/ce.2014.47.4.301. Epub 2014 Jul 28.

  PMID: 25133115 BACKGROUND

• Kochman ML, McClave SA, Boyce HW. The refractory and the recurrent esophageal stricture: a definition. Gastrointest Endosc. 2005 Sep;62(3):474-5. doi: 10.1016/j.gie.2005.04.050. No abstract available.

  PMID: 16111985 BACKGROUND

• Berger M, Ure B, Lacher M. Mitomycin C in the therapy of recurrent esophageal strictures: hype or hope? Eur J Pediatr Surg. 2012 Apr;22(2):109-16. doi: 10.1055/s-0032-1311695. Epub 2012 Apr 19.

  PMID: 22517516 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

• Nagaich N, Nijhawan S, Katiyar P, Sharma R, Rathore M. Mitomycin-C: 'a ray of hope' in refractory corrosive esophageal strictures. Dis Esophagus. 2014 Apr;27(3):203-5. doi: 10.1111/dote.12092. Epub 2013 Jun 24.

  PMID: 23796367 BACKGROUND

• Poddar U, Thapa BR. Benign esophageal strictures in infants and children: results of Savary-Gilliard bougie dilation in 107 Indian children. Gastrointest Endosc. 2001 Oct;54(4):480-4. doi: 10.1067/mge.2001.118253.

  PMID: 11577311 BACKGROUND

MeSH Terms

Conditions

Esophageal Stenosis

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Nagla Abou Faddan, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

ahmed osman, assistant lecturer

CONTACT

01010168440; ahmedzuhry3999@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assiut university children hospital, assistant lecturer ,gastroentrologyand hepatology and endoscopy unit.

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: August 24, 2020
• Study Start: December 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: March 1, 2022
• Last Updated: October 27, 2020

Record last verified: 2020-08