4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen

Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen

Study Description
Brief 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.


Condition or disease Intervention/treatment
Surgery Procedure: exploratory surgery

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Second Affiliated Hospital, College of Medicine, Zhejiang University
Estimated Study Start Date : June 2, 2021
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2026
Arms 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 Name: 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 Name: lateral cervical incision surgery
Outcome Measures
Primary Outcome Measures :
  1. Success rate [ Time Frame: 5 years ]
    Success rate of two groups


Secondary Outcome Measures :
  1. surgery time [ Time Frame: intraoperative ]
    Surgery time of two groups


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People from vulnerable groups are excluded
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hong-Gang Duan, doctor 86(China)-571-87783774 2314061@zju.edu.cn
Contact: Fang Ji, master 86(China)-571-87783774 1506061@zju.edu.cn

Locations
Layout table for location information
China, Zhejiang
Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Contact: Hong-Gang Duan, doctor    86(China)-571-87783774    2314061@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Layout table for investigator information
Study Director: Hong-Gang Duan, doctor Second Affiliated Hospital, College of Medicine, Zhejiang University
Tracking Information
First Submitted Date June 2, 2021
First Posted Date June 8, 2021
Last Update Posted Date June 8, 2021
Estimated Study Start Date June 2, 2021
Estimated Primary Completion Date December 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2021) 		Success rate [ Time Frame: 5 years ]
Success rate of two groups
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 7, 2021) 		surgery time [ Time Frame: intraoperative ]
Surgery time of two groups
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen
Official Title Second Affiliated Hospital, College of Medicine, Zhejiang University
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population People from vulnerable groups are excluded
Condition 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.

Other Name: lateral cervical incision surgery
Study Groups/Cohorts
  • Conventional surgery group
    Conventional surgery with Preoperative foreign body localization
    Intervention: Procedure: exploratory surgery
  • New surgery group
    new surgery with Intraoperative localization of foreign body
    Intervention: Procedure: exploratory surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 7, 2021) 		50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2026
Estimated Primary Completion Date December 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Hong-Gang Duan, doctor 86(China)-571-87783774 2314061@zju.edu.cn
Contact: Fang Ji, master 86(China)-571-87783774 1506061@zju.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04917367
Other Study ID Numbers 2020-152
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Not Provided
Investigators
Study Director: Hong-Gang Duan, doctor Second Affiliated Hospital, College of Medicine, Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date June 2021