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

Primary Purpose

Esophageal Stricture

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Stricture focused on measuring triamcinolole, refractory esophageal stricture, children

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    The use of Triamcinolone Injection

    Arm Description

    Triamcinolone acetate (40 mg/mL)

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 16, 2020
    Last Updated
    October 25, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04524897
    Brief Title
    The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children
    Official Title
    The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    October 2021 (Anticipated)
    Study Completion Date
    March 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate the efficacy of Intra-lesional triamcinolone injection in the management of refractory benign esophageal Stricture in children.
    Detailed Description
    Oesophageal stricture is a commonly encountered clinical problem, especially in gastroenterology. It occurs due to narrowing of oesophagus, which results in swallowing difficulty. Oesophageal stricture has two major types: benign and malignant. Malignant type results from carcinoma but benign type has different causes. Amongst benign aetiologies, gastrointestinal reflux disease (GERD), peptic injury, oesophageal webs, radiation damage, caustic swallowing and anastomotic strictures are most common. Corrosive intake is an important public health issue in developed countries and its incidence is still increasing in developing countries. The problem is largely unreported and its exact prevalence cannot be figured out due to the insufficient reporting or personal experience. Corrosives materials can damage the bodies' tissues, as they come in contact with them. They are usually utilised to clean metals. It can cause severe health hazard, if swallowed accidentally or intentionally. Epidemiological studies have documented corrosive intake as the third most common cause of poisoning in adults. The most common symptom of oesophageal stricture is progressive dysphagia to solids followed by inability to tolerate liquids. These strictures are diagnosed most commonly by using barium swallow, endoscopy and biopsy. Endoscopic dilatation is the most applicable method to treat oesophageal strictures, and proton pump inhibitors (PPIs) are also used to inhibit acid production. According to the Kochman criteria, refractory or recurrent strictures are defined as an anatomic restriction because of a cicatricial luminal compromise or fibrosis resulting in clinical symptoms of dysphagia in the absence of endoscopic evidence of inflammation. This may occur as the result of either an inability to successfully remediate the anatomic problem to a diameter of at least 14 mm over five sessions at two-week intervals (refractory); or as a result of an inability to maintain a satisfactory luminal diameter for four weeks once the target diameter of 14 mm has been achieved (recurrent). This definition is not meant to include patients with an inflammatory stricture (which will not resolve until the inflammation subsides), or those with a satisfactory diameter but having dysphagia on the basis of neuromuscular dysfunction (for example those with dysphagia due to postoperative and/or postradiation therapy). Esophageal rehabilitation has been carried out for many years with different techniques, depending on the experience of each physician, esophageal prostheses or splints, dilations with balloons or Savary-Gilliard plugs, Hurst dilators, etc., have been used, but in reality, there is no worldwide standardization for the management of these patients and even less so for the use of certain substances such as triamcinolone acetonide applied intralesionally, or more recently, topical mitomycin C. Triamcinolone acetonide is a synthetic corticosteroid with a preventive effect on collagen synthesis, fibrosis, and chronic cicatrization that has been used for many years, applied in intralesional injection after esophageal dilations for the purpose of delaying cicatrization and thus reducing the number of dilations. Presently, through many studies, it has been concluded that intralesional corticosteroid injections can be added to standard treatment for corrosive oesophageal stricture. International literature exhibited that intralesional steroid injections help in increasing the diameter because of its anti-inflammatory action.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal Stricture
    Keywords
    triamcinolole, refractory esophageal stricture, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The use of Triamcinolone Injection
    Arm Type
    Other
    Arm Description
    Triamcinolone acetate (40 mg/mL)
    Intervention Type
    Drug
    Intervention Name(s)
    Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children
    Other Intervention Name(s)
    Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation
    Intervention Description
    Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation
    Primary Outcome Measure Information:
    Title
    number of patients show improvement in dysphagia scale after five session of triamcinolone injection
    Description
    number of patients show improvement in dysphagia scale after five session of triamcinolone injection
    Time Frame
    2years
    Secondary Outcome Measure Information:
    Title
    the number of patients who will show complete relieve of dysphagia after five sessions of triamcinolone injection
    Description
    complete abscence of dysphagia after triamcinolone injection
    Time Frame
    2years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed osman, assistant lecturer
    Phone
    01010168440
    Email
    ahmedzuhry3999@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nagla Abou Faddan, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18704454
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23840136
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25559822
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25133115
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16111985
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22517516
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28840483
    Citation
    Ravich WJ. Endoscopic Management of Benign Esophageal Strictures. Curr Gastroenterol Rep. 2017 Aug 24;19(10):50. doi: 10.1007/s11894-017-0591-8.
    Results Reference
    background
    PubMed Identifier
    23796367
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11577311
    Citation
    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.
    Results Reference
    background

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

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