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临床试验/NCT04524897
NCT04524897Unknown4 期

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

Assiut University0 个研究点目标入组 20 人开始时间: 2020年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
20
主要终点
number of patients show improvement in dysphagia scale after five session of triamcinolone injection

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

The use of Triamcinolone Injection

Other

Triamcinolone acetate (40 mg/mL)

干预措施: Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children (Drug)

结局指标

主要结局

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

时间窗: 2years

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

次要结局

  • the number of patients who will show complete relieve of dysphagia after five sessions of triamcinolone injection(2years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Zuhry

assiut university children hospital, assistant lecturer ,gastroentrologyand hepatology and endoscopy unit.

Assiut University

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