Clinical trial NCT06652620: Cola Ingestion for Esophageal Bolus Impaction
Official title: A Prospective, Randomized Controlled Study on Cola Ingestion for Bolus Impaction in Patients With Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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)
2. Prior to enrollment, the patient did not consume carbonated beverages such as cola, or any other treatment for esophageal impaction.
3. Age ≥ 18 years old, ECOG score is 0-2 points.
4. The subjects voluntarily enrolled and obtained an informed consent form signed by the patient or their legal representative.

Exclusion Criteria:

1. It is known that complete esophageal obstruction is caused by tumor progression.
2. Patients who have been diagnosed with or highly suspected of having esophageal fistula through endoscopy or imaging prior to enrollment.
3. Patients with nasogastric nutrition tube and esophageal stent implantation
4. 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).
5. Benign diseases such as gastroesophageal reflux, cardiac arrest, and congenital esophageal stenosis that can easily lead to foreign body impaction in the esophagus.
6. Patients with coagulation dysfunction, thrombocytopenia, or taking anticoagulant drugs that are medically considered contraindications for endoscopic examination and treatment.
7. 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.

Primary outcomes:
measure: 24-hour remission rate of acute esophageal impaction
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: