Oral Cola for Acute Food Bolus Impaction in Patients With Esophageal Cancer: a Prospective, Randomized Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- 24-hour remission rate of acute esophageal impaction
研究概览
简要总结
The aim of the study is to observe whether cola ingestion can improve the 24-hour remission rate of acute esophageal impaction in patients with esophageal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary esophageal lesions diagnosed by pathology, being able to consume at least a liquid diet normally before and diagnosed by a physician with acute esophageal impaction (acute esophageal impaction refers to the sudden occurrence of complete obstruction of eating within the past week)
- •Prior to enrollment, the patient did not consume carbonated beverages such as cola, or any other treatment for esophageal impaction.
- •Age ≥ 18 years old, Eastern Cooperative Oncology Group (ECOG) Performance Status score is 0-2 points.
- •The subjects voluntarily enrolled and obtained an informed consent form signed by the patient or their legal representative.
排除标准
- •It is known that complete esophageal obstruction is caused by tumor progression.
- •Patients who have been diagnosed with or highly suspected of having esophageal fistula through endoscopy or imaging prior to enrollment.
- •Patients with nasogastric nutrition tube and esophageal stent implantation
- •Patients who have symptoms such as coughing and are unable to drink cola, or who are at serious risk of aspiration (Glasgow Coma Scale<14 or previous history of aspiration).
- •Benign diseases such as gastroesophageal reflux, cardiac arrest, and congenital esophageal stenosis that can easily lead to foreign body impaction in the esophagus.
- •Patients with coagulation dysfunction, thrombocytopenia, or taking anticoagulant drugs that are medically considered contraindications for endoscopic examination and treatment.
- •According to the researchers' assessment, patients may not be able to cooperate with the examination and treatment, or there may be other factors that could force them to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concomitant treatment, severe abnormal laboratory test values, family or social factors, which may affect the safety of the patients or the collection of experimental data.
研究组 & 干预措施
Cola ingestion group
Participants in the intervention group are instructed to consume regular Cola in an upright or sitting position after diagnosing with a complete esophageal bolus impaction.
干预措施: Cola (Other)
Control group
Patients in the control group did not receive any pre-endoscopic treatment.This arm includes participants only from Stage 1 (Randomized Phase) of the study.
结局指标
主要结局
24-hour remission rate of acute esophageal impaction
时间窗: The observation interval is from the diagnosis of esophageal impaction and random onset to the relief of esophageal impaction (at least allowing smooth consumption of liquid food) or the first 24-hour interval after diagnosis of esophageal impaction.
The percentage corresponding to the ratio of the number of patients who achieved relief of esophageal impaction (including partial and complete relief) within 24 hours to the total number of patients in the group is the 24-hour relief rate.
次要结局
未报告次要终点
研究者
Kuai Le Zhao, MD
Chief physician
Fudan University