Gastric CancerNCT07359586
Laryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia
An observational study of Gastric Cancer and Hepatic Carcinoma, run by Zhejiang University at 2 sites in China.
Trial summary
This study retrospectively analyzed patients who underwent tracheal intubation under general anesthesia at the First Affiliated Hospital of Zhejiang University School of Medicine between October 1, 2015, and September 30, 2025, with a focus on issues related to postoperativelaryngopharyngeal complaints. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer, Hepatic Carcinoma, Pulmonary Carcinoma
- How many people
- 1,200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2025to 25 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent endotracheal intubation under general anesthesia at the First Affiliated Hospital of Zhejiang University between October 1, 2015, and September 30, 2025
Who may be able to join
- Patients who underwent general anesthesia with tracheal intubation at the First Affiliated Hospital of Zhejiang University School of Medicine between October 2015 and September 2025
- Patients who required otolaryngological consultation due to laryngopharyngeal complaints (including hoarseness, sore throat, cough, choking on drinking water, etc.) postoperatively
- The surgical type was non-otolaryngological surgery
Who cannot join
- Patients with a history of laryngopharyngeal lesions (e.g., granuloma, polyp, tumour, vocal cord paralysis
- Patients with a preexisting tracheotomy
- Patients requiring postoperative tracheotomy
- Patients with incomplete medical records
- Patients who underwent multiple surgeries but for whom the specific surgical episode responsible for the laryngopharyngeal complaints could not be identified
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Completed
he First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Incidence,Perioperative Risk Factors and Prognosis Associated With Laryngopharyngea Injury After Endotracheal Intubation Under General Anesthesia：A Retrospective Study
This study retrospectively analyzed patients who underwent tracheal intubation under general anesthesia at the First Affiliated Hospital of Zhejiang University School of Medicine between October 1, 2015, and September 30, 2025, with a focus on issues related to postoperativelaryngopharyngeal complaints. Patients requiring otolaryngological consultation due to postoperative laryngopharyngeal complaints were identified via the case consultation system. Relevant patient data were collected through the Medison Anesthesia Information Management System and electronic medical record system, and telephone follow-up was conducted to assess patient prognosis. The primary outcome measures were the risk factors of postoperative hoarseness, while the secondary outcome measures included the incidence of postoperative hoarseness, the severity of vocal fold injury and its related risk factors. Additionally, the prognosis of patients and its related risk factors were evaluated. This study aims to reduce the incidence of perioperative laryngopharyngeal injury and provide a reference for the optimization of perioperative anesthetic regimens.
- Conditions
- Gastric Cancer, Hepatic Carcinoma, Pulmonary Carcinoma, Pancreatic Carcinoma, Cholangiocarcinoma, Thyroid Carcinoma
- Keywords
- hoarseness, Vocal cord injury, Incidence, Prognosis
- Medical subject headings
- Stomach Neoplasms, Carcinoma, Hepatocellular, Lung Neoplasms, Pancreatic Neoplasms, Cholangiocarcinoma, Thyroid Neoplasms, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hoarseness | We collected perioperative clinical data from the cohort, analyzed the associated risk factors for the occurrence of relevant symptoms, and investigated the prognosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hoarseness
The patients underwent general anesthesia with tracheal intubation and required otolaryngological consultation for hoarseness between October 1, 2015, and September 30, 2025.Hoarseness is characterized by alterations in voice quality, pitch (how high or low the voice is), volume (loudness), or vocal effort that impair effective communication, as judged by a healthcare provider, and may adversely affect quality of life.
Measured: Perioperative,up to150 days
Secondary outcomes (4)
Incidence of Hoarseness
(Number of patients with postoperative hoarseness） / (Total number of patients undergoing general anesthesia tracheal intubation) × 100%
Measured: Perioperative,up to150 days
the severity of hoarseness
Hoarseness was assessed as follows: 0 = none (no hoarseness), 1 = noticed by patient, 2 = obvious to observer, 3 = aphonia.
Measured: Perioperative,up to150 days
Postoperative Vocal Fold Injury
Based on patients' hoarseness symptoms and laryngoscopic findings, an otolaryngologist conducted clinical assessment and grading, classifying vocal fold injury into four levels. The classification criteria were: Grade 0 (Normal): Non-hoarsenes; Grade 1 (Mild): hoarseness with negative laryngoscopic findings or vocal fold closure gap; Grade 2 (Moderate): hoarseness with vocal fold mobility impairment; Grade 3 (Severe): hoarseness with vocal cord paralysis or fixation.
Measured: Perioperative,up to150 days
Incidence of Arytenoid Dislocation
(Number of patients with postoperative arytenoid dislocation)/ (Total number of patients undergoing general anesthesia tracheal intubation) × 100%
Measured: Perioperative,up to150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Nov 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
- Investigators
- Diansan Su, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359586
- Sponsor's protocol ID
- ZJU2025B0596
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence,Perioperative Risk Factors and Prognosis Associated With Laryngopharyngea Injury After Endotracheal Intubation Under General Anesthesia：A Retrospective Study
- ClinicalTrials.gov ID
- NCT07359586
- Acronym / sponsor ID
- ZJU2025B0596
- Conditions
- Gastric Cancer, Hepatic Carcinoma, Pulmonary Carcinoma, Pancreatic Carcinoma, Cholangiocarcinoma, Thyroid Carcinoma
- Keywords
- hoarseness, Vocal cord injury, Incidence, Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
This study retrospectively analyzed patients who underwent tracheal intubation under general anesthesia at the First Affiliated Hospital of Zhejiang University School of Medicine between October 1, 2015, and September 30, 2025, with a focus on issues related to postoperativelaryngopharyngeal complaints. Patients requiring otolaryngological consultation due to postoperative laryngopharyngeal complaints were identified via the case consultation system. Relevant patient data were collected through the Medison Anesthesia Information Management System and electronic medical record system, and telephone follow-up was conducted to assess patient prognosis. The primary outcome measures were the risk factors of postoperative hoarseness, while the secondary outcome measures included the incidence of postoperative hoarseness, the severity of vocal fold injury and its related risk factors. Additionally, the prognosis of patients and its related risk factors were evaluated. This study aims to reduce the incidence of perioperative laryngopharyngeal injury and provide a reference for the optimization of perioperative anesthetic regimens.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hoarseness | – | –We collected perioperative clinical data from the cohort, analyzed the associated risk factors for the occurrence of relevant symptoms, and investigated the prognosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent endotracheal intubation under general anesthesia at the First Affiliated Hospital of Zhejiang University between October 1, 2015, and September 30, 2025
Key inclusion criteria (3 listed)
- Patients who underwent general anesthesia with tracheal intubation at the First Affiliated Hospital of Zhejiang University School of Medicine between October 2015 and September 2025
- Patients who required otolaryngological consultation due to laryngopharyngeal complaints (including hoarseness, sore throat, cough, choking on drinking water, etc.) postoperatively
- The surgical type was non-otolaryngological surgery
Key exclusion criteria (5 listed)
- Patients with a history of laryngopharyngeal lesions (e.g., granuloma, polyp, tumour, vocal cord paralysis
- Patients with a preexisting tracheotomy
- Patients requiring postoperative tracheotomy
- Patients with incomplete medical records
- Patients who underwent multiple surgeries but for whom the specific surgical episode responsible for the laryngopharyngeal complaints could not be identified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative hoarseness
Time frame: Perioperative,up to150 days
The patients underwent general anesthesia with tracheal intubation and required otolaryngological consultation for hoarseness between October 1, 2015, and September 30, 2025.Hoarseness is characterized by alterations in voice quality, pitch (how high or low the voice is), volume (loudness), or vocal effort that impair effective communication, as judged by a healthcare provider, and may adversely affect quality of life.
4 secondary outcomes
Incidence of Hoarseness
Time frame: Perioperative,up to150 days
the severity of hoarseness
Time frame: Perioperative,up to150 days
Postoperative Vocal Fold Injury
Time frame: Perioperative,up to150 days
Incidence of Arytenoid Dislocation
Time frame: Perioperative,up to150 days
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 22 Jan 2026.
- 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.
Diansan Su principal investigator
First Affiliated Hospital of Zhejiang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Hepatic Carcinoma, run by Zhejiang University at 2 sites 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 3 inclusion and 5 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Diansan Su (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hoarseness (time frame: Perioperative,up to150 days). 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 22 Jan 2026.