Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen

Second Affiliated Hospital, College of Medicine, Zhejiang University

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery
• Intervention / Treatment: Procedure: exploratory surgery

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Hong-Gang Duan, doctor; Phone Number: 86(China)-571-87783774; Email: 2314061@zju.edu.cn
• Study Contact Backup: Name: Fang Ji, master; Phone Number: 86(China)-571-87783774; Email: 1506061@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University
      • Contact: Hong-Gang Duan, doctor; Phone Number: 86(China)-571-87783774; Email: 2314061@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People from vulnerable groups are excluded

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conventional surgery group; Conventional surgery with Preoperative foreign body localization	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.; Other Names: lateral cervical incision surgery
New surgery group; new surgery with Intraoperative localization of foreign body	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.; Other Names: lateral cervical incision surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate	Success rate of two groups	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery time	Surgery time of two groups	intraoperative

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Hong-Gang Duan, doctor, Second Affiliated Hospital, College of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Anticipated): December 30, 2025
• Study Completion (Anticipated): December 30, 2026

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Migrating foreign body; Upper aerodigestive tract; Neck; Laryngoscopy endoscopy; Positioning
• Additional Relevant MeSH Terms: Wounds and Injuries; Foreign Bodies
• Other Study ID Numbers: 2020-152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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