Cola Ingestion for Esophageal Bolus Impaction

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Other: Cola

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Fujian
    • Xiamen, Fujian, China
      • Fudan University Shanghai Cancer Center Xiamen Hospital
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • The Northern Jiangsu People's Hospital
  • Jiangxi
    • Jingdezhen, Jiangxi, China
      • First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, Eastern Cooperative Oncology Group (ECOG) Performance Status 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Patients in the control group did not receive any pre-endoscopic treatment.
Experimental: 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.	Other: Cola; regular Coca-Cola (Coca-Cola company, Atlanta, GA) or Pesi-cola (PepsiCo, Inc.New York, NY)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour remission rate of acute 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.	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.

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): February 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ESO-Shanghai24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No