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