Esophageal StricturePhase 4NCT04524897
The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children
A Phase 4 study testing Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children in people with Esophageal Stricture, run by Assiut University.
Trial summary
To evaluate the efficacy of Intra-lesional triamcinolone injection in the management of refractory benign esophageal Stricture in children. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Esophageal Stricture
- What is being tested?
- Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
To evaluate the efficacy of Intra-lesional triamcinolone injection in the management of refractory benign esophageal Stricture in children.
Read the 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.
- Conditions
- Esophageal Stricture
- Being tested
- Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children
- Keywords
- triamcinolole, refractory esophageal stricture, children
- Medical subject headings
- Esophageal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in childrenDrug
Also called Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation
Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation
| Study group | Role | What they receive |
|---|---|---|
| The use of Triamcinolone Injection | Other | Triamcinolone acetate (40 mg/mL) Receives: Drug: Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2years
Secondary outcomes (1)
the number of patients who will show complete relieve of dysphagia after five sessions of triamcinolone injection
complete abscence of dysphagia after triamcinolone injection
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start1 Dec 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zuhry, Assiut University
- Investigators
- Nagla Abou Faddan, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524897
- Sponsor's protocol ID
- TIRBESC
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18704454Contini 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.
PubMed 23840136Mowry 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.
PubMed 25559822Park 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.
PubMed 25133115Kochman 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.
PubMed 16111985Berger 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.
PubMed 22517516Ravich WJ. Endoscopic Management of Benign Esophageal Strictures. Curr Gastroenterol Rep. 2017 Aug 24;19(10):50. doi: 10.1007/s11894-017-0591-8.
PubMed 28840483Nagaich 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.
PubMed 23796367Poddar 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.
PubMed 11577311
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children
- ClinicalTrials.gov ID
- NCT04524897
- Acronym / sponsor ID
- TIRBESC
- Conditions
- Esophageal Stricture
- Keywords
- triamcinolole, refractory esophageal stricture, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The use of Triamcinolone Injection | Other | Drug: Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in childrenTriamcinolone acetate (40 mg/mL) |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in childrenAlso: Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatationTriamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation | Drug | The use of Triamcinolone Injection |
Primary outcome
number of patients show improvement in dysphagia scale after five session of triamcinolone injection
Time frame: 2years
number of patients show improvement in dysphagia scale after five session of triamcinolone injection
1 secondary outcome
the number of patients who will show complete relieve of dysphagia after five sessions of triamcinolone injection
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Background: PubMed 18704454Morikawa 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.
- Background: PubMed 23840136Contini 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.
- Background: PubMed 25559822Mowry 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.
- Background: PubMed 25133115Park 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.
- Background: PubMed 16111985Kochman 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.
- Background: PubMed 22517516Berger 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.
- Background: PubMed 28840483Ravich WJ. Endoscopic Management of Benign Esophageal Strictures. Curr Gastroenterol Rep. 2017 Aug 24;19(10):50. doi: 10.1007/s11894-017-0591-8.
- Background: PubMed 23796367Nagaich 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.
- Background: PubMed 11577311Poddar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagla Abou Faddan, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children in people with Esophageal Stricture, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed osman, assistant lecturer (01010168440, ahmedzuhry3999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients show improvement in dysphagia scale after five session of triamcinolone injection (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04524897, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.