Cola Ingestion for Esophageal Bolus Impaction

NCT06652620 | Active Not Recruiting DMC

• 1 other identifier: ESO-Shanghai24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Cola ingestion group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in the control group did not receive any pre-endoscopic treatment.

Interventions

Cola OTHER

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

Cola ingestion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (4)

Fudan University Shanghai Cancer Center Xiamen Hospital

Xiamen, Fujian, China

Location

The Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

First People's Hospital

Jingdezhen, Jiangxi, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: November 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)