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临床试验/NCT04309825
NCT04309825撤回不适用

Efficacy of Transgastrostomal Esophagogastroduodenoscopies in Children

Yale University2 个研究点 分布在 1 个国家开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Obtain adequate biopsies

研究概览

简要总结

Upper GI endoscopies are commonly done by inserting the endoscope through the patient's mouth. When a patient has a gastrostomy feeding tube, the endoscope can be inserted through the stomach port opening. The aim is to prove this modification would lead to various health benefits, including need for lighter anesthesia, rapid recovery time and fewer anesthesia related adverse reactions.

详细描述

Pediatric esophagogastroduodenoscopies (EGD) are commonly used for diagnosis and treatment of various GI conditions. Appropriate sedation or anesthesia and analgesia is critical for enhancing the effectiveness and feasibility of EGD. General anesthesia or deep sedation are commonly used for this procedure. Midazolam is the most common intravenous sedative in use, often in combination with ketamine, propofol, meperidine or fentanyl.

Despite technical advances in patient monitoring and the safety of anesthesia and sedation drugs, procedural anesthesia or sedation adverse events may occur. Desaturation during the procedure is the most common adverse event, followed by vomiting, excessive secretion and unexpected apnea. Children with aero-digestive pathologies and feeding disorders often carry significant underlying co-morbidities, increasing their anesthesia risk. Previous studies have shown that caution must be exercised in children with potential airway problems or uncorrected cardiopulmonary anomalies such as laryngomalacia, chromosomal abnormalities, tetralogy of fallot and bronchopulmonary dysplasia. In addition, this population is often at increased risk for concurrent respiratory conditions, which may increase the risk for laryngospasm during the procedure.

As the endoscope is inserted transorally, it may also be an important trigger for laryngospasm. Alternatives to oral insertion of the endoscope have been described and shown to be more beneficial than the oral route in some patients. For example, previous studies have shown that transnasal endoscopies are known to be less of a burden to patients, and have benefits including fewer effects on respiratory and cardiovascular status and reduced recovery time after procedure.

Alternatively, insertion of the endoscope through the gastrocutaneous tract is possible among patients with a percutaneous gastrostomy feeding tube. This technique has been well described in the adult population for observation, diagnosis and treatment of various digestive diseases. As children with aero-digestive and feeding disorders often have a percutaneous gastrostomy feeding tube, and are at increased risk for anesthesia adverse events, transgastrostomal endoscopies me be beneficial in this patient population. To date, this method has not been reported and examined in children undergoing EGDs.

The aims of this study:

研究设计

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

入排标准

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

入选标准

  • children with a percutaneous gastrostomy feeding tube, who are about to have a diagnostic esophagogastroduodenoscopy.

排除标准

  • age>18 years,
  • G-tube size <12Fr.
  • Patients with immature gastrocutaneous fistula (< 4 weeks after gastrostomy)

结局指标

主要结局

Obtain adequate biopsies

时间窗: 15 minutes

Conduct a full endoscopy via g-tube port. Advance the scope to all standard locations including proximal esophagus, distal esophagus, stomach, duodenal bulb and the second part of the duodenum. Obtain at least 2 specimens from each location.

次要结局

  • anesthesia related adverse reactions(15 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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