Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen

Surgery Clinical Trial

Official title:

Second Affiliated Hospital, College of Medicine, Zhejiang University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04917367
• Other study ID #: 2020-152
• Status: Recruiting
• Start date: July 2, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Hong-Gang Duan, doctor
• Phone: 86(China)-571-87783774
• Email: 2314061[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective: To improve the success rate of the treatment of migrating foreign bodies in the upper aerodigestive tract.

Methods: The medical records of inpatients conforming to the diagnosis of migrating foreign bodies between 2020 and 2025 were reviewed. Data regarding age, gender, time from onset to hospitalization, computed tomography (CT) and endoscopic scans, surgical procedures，and follow-up were collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The foreign body of pharynx or esophagus was confirmed by surgical exploration

Exclusion Criteria:

• The foreign body is in the pharynx or esophagus or is not found during surgery.

Related Conditions & MeSH terms

• Foreign Bodies
• Surgery

Intervention

Procedure:
• exploratory surgery
For foreign bodies in the retropharyngeal space or parapharyngeal space above the esophageal entrance, close to the laryngopharynx cavity with large operating space, suspension laryngoscopy is the first choice according to the principle of proximity. In all cases, a lateral cleft laryngoscope was used to expose the posterior or lateral wall of the laryngopharynx, and 30° endoscope or microscope was used according to the skills of the surgeon. For a foreign body below the esophageal entrance, the lateral cervical incision was the first choice due to the small operating space of oral exposure. The lateral cervical incision and other open surgical methods are used for foreign bodies below the entrance of the esophagus or in the submaxillary space or for the anterior cervical band muscle foreign bodies.

Locations

Country	Name	City	State
China	Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	Success rate of two groups	5 years
Secondary	surgery time	Surgery time of two groups	intraoperative