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Trial Title:
Cola Ingestion for Esophageal Bolus Impaction
NCT ID:
NCT06652620
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Cola
Description:
regular Coca-Cola (Coca-Cola company, Atlanta, GA) or Pesi-cola (PepsiCo, Inc.New York,
NY)
Arm group label:
Intervention group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Kuaile Zhao, M.D.
Phone:
86-18017312534
Email:
kuaile_z@fudan.edu.cn
Start date:
October 1, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06652620
