SurgeryNCT04917367
Diagnosis and Treatment of Foreign Bodies Outside Pharynx and Esophagus Lumen
An observational study of Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery
- What is being tested?
- exploratory surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2021to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People from vulnerable groups are excluded
Who may be able to join
- The foreign body of pharynx or esophagus was confirmed by surgical exploration
Who cannot join
- The foreign body is in the pharynx or esophagus or is not found during surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Hong-Gang Duan, doctor, 86(China)-571-87783774, 2314061@zju.edu.cn
About this study
Official title: 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.
- Conditions
- Surgery
- Being tested
- exploratory surgery
- Keywords
- Migrating foreign body; Upper aerodigestive tract; Neck; Laryngoscopy endoscopy; Positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exploratory surgeryProcedure or surgery
Also called lateral cervical incision 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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery group | Conventional surgery with Preoperative foreign body localization Receives: Procedure: exploratory surgery | |
| New surgery group | new surgery with Intraoperative localization of foreign body Receives: Procedure: exploratory surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
Success rate of two groups
Measured: 5 years
Secondary outcomes (1)
surgery time
Surgery time of two groups
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start2 Jul 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong-Gang Duan, doctor, Study director, Second Affiliated Hospital, College of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917367
- Sponsor's protocol ID
- 2020-152
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Affiliated Hospital, College of Medicine, Zhejiang University
- ClinicalTrials.gov ID
- NCT04917367
- Acronym / sponsor ID
- 2020-152
- Conditions
- Surgery
- Keywords
- Migrating foreign body; Upper aerodigestive tract; Neck; Laryngoscopy endoscopy; Positioning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery group | – | Procedure: exploratory surgeryConventional surgery with Preoperative foreign body localization |
| New surgery group | – | Procedure: exploratory surgerynew surgery with Intraoperative localization of foreign body |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People from vulnerable groups are excluded
Key inclusion criteria (1 listed)
- The foreign body of pharynx or esophagus was confirmed by surgical exploration
Key exclusion criteria (1 listed)
- The foreign body is in the pharynx or esophagus or is not found during surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exploratory surgeryAlso: lateral cervical incision surgeryFor 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. | Procedure or surgery | Conventional surgery group, New surgery group |
Primary outcome
Success rate
Time frame: 5 years
Success rate of two groups
1 secondary outcome
surgery time
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong-Gang Duan, doctor study director
Second Affiliated Hospital, College of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong-Gang Duan, doctor (86(China)-571-87783774, 2314061@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.