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Cola Ingestion for Esophageal Bolus Impaction

NCT ID: NCT06652620

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cola

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cola

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Kuai Le Zhao, MD

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

Site Status RECRUITING

First People's Hospital

Jingdezhen, Jiangxi, China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ting Yin, M.D.

Role: primary

Qian Wang, M.D.

Role: primary

Kuaile Zhao, M.D.

Role: primary

Other Identifiers

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ESO-Shanghai24

Identifier Type: -

Identifier Source: org_study_id