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OpenTrials
Active, Not Recruiting

NCT Number: NCT06652620

Cola Ingestion for Esophageal Bolus Impaction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center Xiamen Hospital, Xiamen, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Cola

Other

regular Coca-Cola (Coca-Cola company, Atlanta, GA) or Pesi-cola (PepsiCo, Inc.New York, NY)

Primary outcomes

  1. 24-hour remission rate of acute esophageal impaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Prospective, Randomized Controlled Study on Cola Ingestion for Bolus Impaction in Patients With Esophageal Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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