Efficacy of Carbonated Beverages in the Resolution of Alimentary Esophageal Impaction

NCT06313060 | Completed

• 1 other identifier: 010
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To evaluate the efficacy of the administration of carbonated beverages in the resolution of dietary esophageal impaction, and to identify subgroups in which their effectiveness may be different: patients with/without esophageal diseases, with/without a history of impaction. Methods: A clinical trial was conducted randomizing consecutive patients with a clinical diagnosis of dietary esophageal impaction to receive 200cc of carbonated drink or not at all, excluding patients with a previous diagnosis of non-esophageal stenosis that could not be overcome with a gastroscope and suspected impaction by non-alimentary foreign bodies, spines or bones. Subsequently, an endoscopic evaluation will be carried out in all cases, checking the presence or absence of a foreign body and removing it if necessary, as well as assessing and recording the possible underlying esophageal pathology. A telephone follow-up will be carried out after 7 days, recording possible adverse events.

Conditions

Esophagus Disorder

Outcome Measures

Primary Outcomes (1)

• Efficacy of carbonated beverage for disimpaction

  Number of patients with esophageal impaction resolved with the carbonated beverage

  3 years

Study Arms (2)

Intervention group

EXPERIMENTAL

200 ml of Coca-Cola will be administered and must be ingested within a maximum of 10 minutes

Dietary Supplement: Coca-cola

Control group

NO INTERVENTION

will not receive any type of medication or drink

Interventions

Coca-cola DIETARY_SUPPLEMENT

200 ml of Coca-Cola will be administered and must be ingested within a maximum of 10 minutes

Intervention group

Eligibility Criteria

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

You may qualify if:

• Patients who come to the Emergency Department with a clinical diagnosis of esophageal impaction due to food bolus (determined by at least one of the following symptoms: sialorrhea, inability to swallow or cervical or retrosternal foreign body sensation) that requires endoscopic extraction.

You may not qualify if:

• Pregnancy.
• Benign or malignant esophageal stricture that cannot be overcome with a conventional gastroscope.
• Patients with intraesophageal prostheses
• Non-food foreign body (includes fish bones or bones)
• Ingestion of some type of carbonated beverage after impaction.
• Contraindication for the administration of carbonated drink (Cola-Cola) due to allergy or intolerance to any of its components.

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (1)

Manuel Perez-Miranda

Valladolid, Spain

Location

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 15, 2024
• Study Start: March 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)