Laryngeal CancerSPPDPLNCT06024980
Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy
A study testing Open partial horizontal laryngectomy(OPHL), Type I-III and Transoral endoscopic laser cordectomy in people with Laryngeal Cancer and Dysphagia, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Recruited patients are divided into two arms depending on laryngeal carcinoma's T1 and T2 stages. Two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (OPHL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laryngeal Cancer, Dysphagia
- What is being tested?
- Open partial horizontal laryngectomy(OPHL), Type I-III and Transoral endoscopic laser cordectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years
- Surgical treatment by open partial horizontal laryngectomy type I or II and transoral laser cordectomy for squamous cell carcinoma
- Availability of clinical data
- Validity of normal swallowing of thin liquids
Who cannot join
- Presence of severe chronic obstructive pulmonary disease, severe heart disease, and psychopathy or mental disease
- Surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision)
- Radiotherapy histology
- Swallowing disorder or trachea aspiration before surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's hospital
Guangzhou, Guangdong, 510080
Pingjiang Ge, +8613751753465, gepingjiang@aliyun.com
About this study
Official title: Department of Otolaryngology Head Neck Surg
Recruited patients are divided into two arms depending on laryngeal carcinoma's T1 and T2 stages. Two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (OPHL). During the pre-and post-operative time, patients performed measurements of swallowing function, including direct subglottic pressure, Eating Assessment Tool-10(EAT-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(FEES). Patients undergo subglottic pressure measurement and swallowing function evaluation three times: 3-7 days, two months, and six months after surgery. Patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation.
Read the detailed description
There were swallowing disorders after partial laryngectomy in most patients with laryngeal carcinoma. At least these patients need several months to recover. Few people required surgery of total laryngectomy to maintain normal swallowing function. The swallowing training cannot acquire a valid swallowing function and take the risk of aspiration pneumonia. Factors that influenced the swallowing function recovery, for example, the time of nasogastric feeding and tracheostomy tube removal, were affected by age and diabetes.
On the other hand, the pharynx size of a CT scan can predict the recovery of swallowing function after laryngectomy. But those are not directly related to swallowing motion, although they are predictors of dysphagia. The investigators will perform the study with swallowing function measures to find predictors relative to swallowing function and evaluate dysphagia's recovery early.
Subglottic pressure is a protective factor that can reduce aspiration risk. This research will measure the subglottic pressure after laryngectomy and predict or monitor swallowing disorders. Specific objectives were to verify the effect of laryngectomy on subglottic pressure.
- Conditions
- Laryngeal Cancer, Dysphagia
- Being tested
- Open partial horizontal laryngectomy(OPHL), Type I-III, Transoral endoscopic laser cordectomy
- Keywords
- partial laryngectomy, subglottic pressure, laser
- Medical subject headings
- Laryngeal Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open partial horizontal laryngectomy(OPHL), Type I-IIIProcedure or surgery
Also called Type I OPHLs(formerly defined horizontal supraglottic laryngectomy), Type II (previously called supracricoid laryngectomy), and Type III (also named supratracheal laryngectomy).
An open partial horizontal laryngectomy(OPHL) was performed for patients with T2 supraglottic and glottic carcinoma, according to the American Joint Committee on Cancer(AJCC) criteria. Type I OPHL: Entails the resection of the supraglottis, including the pre-epiglottic space and the upper half of the thyroid cartilage. Type II OPHL: Entails the resection of the entire thyroid cartilage, with the inferior limit represented by the upper edge of the cricoid ring. Type III OPHL: Entails the resection of the entire supraglottic, glottic, and part of the subglottic sites, sparing both or at least one functioning crico-arytenoid unit.
Transoral endoscopic laser cordectomyProcedure or surgery
Also called Transoral carbon dioxide(CO2) laser microsurgery
For patients with T1 glottic laryngeal carcinoma, according to the criteria of the American Joint Committee on Cancer(AJCC), transoral endoscopic CO2 laser(2-40Watts) cordectomy was performed. The classification comprises eight types of cordectomies:
- A subepithelial cordectomy (type I) is a resection of the epithelium of the vocal fold.
- A subligamental cordectomy (type II) is a resection of the epithelium, Reinke's space, and vocal ligament.
- Transmuscular cordectomy (type III), which proceeds through the vocalis muscle.
- Total cordectomy (type IV).
- Extended cordectomy encompasses the contralateral vocal fold and the anterior commissure (type Va).
- Extended cordectomy, which includes the arytenoid (type Vb).
- Extended cordectomy, which encompasses the subglottis (type Vc).
- Extended cordectomy, which consists of the ventricle (type Vd).
| Study group | Role | What they receive |
|---|---|---|
| Supraglottic and glottic T2 laryngeal carcinoma | Active comparator | The open partial horizontal laryngectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T2 Receives: Procedure: Open partial horizontal laryngectomy(OPHL), Type I-III |
| Supraglottic and glottic T1 laryngeal carcinoma | Active comparator | The transoral endoscopic laser cordectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T1 Receives: Procedure: Transoral endoscopic laser cordectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fiberoptic laryngoscope evaluation of swallowing
The patient, in a sitting position, had to swallow liquid. The tip of a flexible endoscope was positioned beyond the soft palate, and the pharyngeal phase of swallowing was studied, recording videos and images for further analysis. In particular, according to the severity scale, the scores ranged from 1 point (no materials entered the airway) to 8 points (the material penetrated below the vocal cords, but no effort was made to eject the material), representing the severity of risk for penetration
Measured: Pre-operation, one week post-operation, two months post-operation, six months post-operation
direct subglottic pressure
Subglottic pressure was measured while swallowing a thinned solution with and without airflow delivery through the subglottic puncture needle. The unit of subglottic pressure is cmH20.
Measured: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
EAT-10 questionnaire
The EAT-10 questionnaire consists of a 10-item questionnaire with a maximum total score of 40 points. All items are rated on a 5-point scale in which 0 indicates no problem, and 4 indicates a severe problem in swallowing function. An EAT-10 score of over 3 is abnormal and indicates a higher self-perception of the presence of dysphagia.
Measured: At one day before surgery, two months after surgery, six months after surgery
Swallowing ability to four different textures
An early 5-point scoring system (score one corresponding to the early postoperative assessment) was applied to each patient depending on his ability to swallow one to four different textures (liquid, semi-liquid, semi-solid, and solid). A score of 0 is poor (no power to swallow), while a score of 4 is good.
Measured: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Secondary outcomes (2)
Voice acoustic analysis
Every participant was asked to phonate a sustained vowel /a/ at a habitual comfortable pitch and intensity for voice pitch, quality assessments, and habitual vocal intensity. The recordings were made in a quiet clinical room. The participant sat in front of a microphone positioned approximately 10cm from the left corner of the mouth. The voice signal coupled with Roland's Audio interface with a sampling rate of 44k-Hz and 16-bit accuracy. The signal was stored in a computer system after collecting sustained vowels. The voice signals were analyzed using speech analysis software. The stable phase of the voice sample was extracted for analysis. The 3,000-msec sample was analyzed for acoustic parameters. The voice acoustic parameters include F0 (fundamental frequency) in Hertz(Hz), percentage of jitter(%), percentage of shimmer(%), Harmonic to noise ratio(HNR), and intensity in decibels(dB).
Measured: At one day before surgery, six months after surgery
The time in weeks of nasogastric feeding
The duration of surgery to oral feeding after withdrawing naso tube.
Measured: At two months after surgery, six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start3 Jan 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Laryngeal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xujiao Chen, Ms, Principal investigator, Guangdong Provicial People's Hospital（Guangdong Academy of Sciences), Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024980
- Sponsor's protocol ID
- 2022-59
- Acronym
- SPPDPL
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bagwell K, Leder SB, Sasaki CT. Is partial laryngectomy safe forever? Am J Otolaryngol. 2015 May-Jun;36(3):437-41. doi: 10.1016/j.amjoto.2014.11.005. Epub 2014 Nov 20.
PubMed 25595047Freitas AS, Santos IC, Furia C, Dornelas R, Silva ACAE, Dias FL, Salles GF. Prevalence and associated factors of aspiration and severe dysphagia in asymptomatic patients in the late period after open partial laryngectomy: a videofluoroscopic evaluation. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3695-3703. doi: 10.1007/s00405-021-07231-4. Epub 2022 Jan 4.
PubMed 34982204Breunig C, Benter P, Seidl RO, Coordes A. Predictable swallowing function after open horizontal supraglottic partial laryngectomy. Auris Nasus Larynx. 2016 Dec;43(6):658-65. doi: 10.1016/j.anl.2016.01.003. Epub 2016 Feb 4.
PubMed 26853312Dawson C, Pracy P, Patterson J, Paleri V. Rehabilitation following open partial laryngeal surgery: key issues and recommendations from the UK evidence based meeting on laryngeal cancer. J Laryngol Otol. 2019 Mar;133(3):177-182. doi: 10.1017/S0022215119000483.
PubMed 30983563Clarett M, Andreu MF, Salvati IG, Donnianni MC, Montes GS, Rodriguez MG. [Effect of subglottic air insufflation on subglottic pressure during swallowing]. Med Intensiva. 2014 Apr;38(3):133-9. doi: 10.1016/j.medin.2013.01.003. Epub 2013 Mar 6. Spanish.
PubMed 23473519Alaskarov E, Ozturk O, Batioglu-Karaaltin A, Gulmez ZD, Erdur ZB, Inan HC. Functional Outcomes of the Hyaluronic Acid Injections in Patients Who Underwent Partial Laryngectomy. J Voice. 2022 May;36(3):417-422. doi: 10.1016/j.jvoice.2020.06.026. Epub 2020 Jul 22.
PubMed 32712078Fakhry N, Michel J, Giorgi R, Robert D, Lagier A, Santini L, Moreddu E, Puymerail L, Adalian P, Dessi P, Giovanni A. Analysis of swallowing after partial frontolateral laryngectomy with epiglottic reconstruction for glottic cancer. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2013-20. doi: 10.1007/s00405-013-2750-3. Epub 2013 Oct 8.
PubMed 24100885
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Otolaryngology Head Neck Surg
- ClinicalTrials.gov ID
- NCT06024980
- Acronym / sponsor ID
- SPPDPL / 2022-59
- Conditions
- Laryngeal Cancer, Dysphagia
- Keywords
- partial laryngectomy, subglottic pressure, laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 Sep 2023 (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.
Recruited patients are divided into two arms depending on laryngeal carcinoma's T1 and T2 stages. Two interventions were undergone, including transoral endoscopic laser cordectomy and open partial horizontal laryngectomy (OPHL). During the pre-and post-operative time, patients performed measurements of swallowing function, including direct subglottic pressure, Eating Assessment Tool-10(EAT-10) questionnaire, swallowing ability to different textures, and fiberoptic evaluation of swallowing(FEES). Patients undergo subglottic pressure measurement and swallowing function evaluation three times: 3-7 days, two months, and six months after surgery. Patients also performed measurement voice acoustic analysis and subjective assessment one-day pre-operation and six months post-operation.
Detailed description
There were swallowing disorders after partial laryngectomy in most patients with laryngeal carcinoma. At least these patients need several months to recover. Few people required surgery of total laryngectomy to maintain normal swallowing function. The swallowing training cannot acquire a valid swallowing function and take the risk of aspiration pneumonia. Factors that influenced the swallowing function recovery, for example, the time of nasogastric feeding and tracheostomy tube removal, were affected by age and diabetes.
On the other hand, the pharynx size of a CT scan can predict the recovery of swallowing function after laryngectomy. But those are not directly related to swallowing motion, although they are predictors of dysphagia. The investigators will perform the study with swallowing function measures to find predictors relative to swallowing function and evaluate dysphagia's recovery early.
Subglottic pressure is a protective factor that can reduce aspiration risk. This research will measure the subglottic pressure after laryngectomy and predict or monitor swallowing disorders. Specific objectives were to verify the effect of laryngectomy on subglottic pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraglottic and glottic T2 laryngeal carcinoma | Active comparator | Procedure: Open partial horizontal laryngectomy(OPHL), Type I-IIIThe open partial horizontal laryngectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T2 |
| Supraglottic and glottic T1 laryngeal carcinoma | Active comparator | Procedure: Transoral endoscopic laser cordectomyThe transoral endoscopic laser cordectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-80 years
- Surgical treatment by open partial horizontal laryngectomy type I or II and transoral laser cordectomy for squamous cell carcinoma
- Availability of clinical data
- Validity of normal swallowing of thin liquids
Key exclusion criteria (4 listed)
- Presence of severe chronic obstructive pulmonary disease, severe heart disease, and psychopathy or mental disease
- Surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision)
- Radiotherapy histology
- Swallowing disorder or trachea aspiration before 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 |
|---|---|---|
| Open partial horizontal laryngectomy(OPHL), Type I-IIIAlso: Type I OPHLs(formerly defined horizontal supraglottic laryngectomy), Type II (previously called supracricoid laryngectomy), and Type III (also named supratracheal laryngectomy).An open partial horizontal laryngectomy(OPHL) was performed for patients with T2 supraglottic and glottic carcinoma, according to the American Joint Committee on Cancer(AJCC) criteria. Type I OPHL: Entails the resection of the supraglottis, including the pre-epiglottic space and the upper half of the thyroid cartilage. Type II OPHL: Entails the resection of the entire thyroid cartilage, with the inferior limit represented by the upper edge of the cricoid ring. Type III OPHL: Entails the resection of the entire supraglottic, glottic, and part of the subglottic sites, sparing both or at least one functioning crico-arytenoid unit. | Procedure or surgery | Supraglottic and glottic T2 laryngeal carcinoma |
| Transoral endoscopic laser cordectomyAlso: Transoral carbon dioxide(CO2) laser microsurgeryFor patients with T1 glottic laryngeal carcinoma, according to the criteria of the American Joint Committee on Cancer(AJCC), transoral endoscopic CO2 laser(2-40Watts) cordectomy was performed. The classification comprises eight types of cordectomies: * A subepithelial cordectomy (type I) is a resection of the epithelium of the vocal fold. * A subligamental cordectomy (type II) is a resection of the epithelium, Reinke's space, and vocal ligament. * Transmuscular cordectomy (type III), which proceeds through the vocalis muscle. * Total cordectomy (type IV). * Extended cordectomy encompasses the contralateral vocal fold and the anterior commissure (type Va). * Extended cordectomy, which includes the arytenoid (type Vb). * Extended cordectomy, which encompasses the subglottis (type Vc). * Extended cordectomy, which consists of the ventricle (type Vd). | Procedure or surgery | Supraglottic and glottic T1 laryngeal carcinoma |
Primary outcome
Fiberoptic laryngoscope evaluation of swallowing
Time frame: Pre-operation, one week post-operation, two months post-operation, six months post-operation
The patient, in a sitting position, had to swallow liquid. The tip of a flexible endoscope was positioned beyond the soft palate, and the pharyngeal phase of swallowing was studied, recording videos and images for further analysis. In particular, according to the severity scale, the scores ranged from 1 point (no materials entered the airway) to 8 points (the material penetrated below the vocal cords, but no effort was made to eject the material), representing the severity of risk for penetration
direct subglottic pressure
Time frame: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Subglottic pressure was measured while swallowing a thinned solution with and without airflow delivery through the subglottic puncture needle. The unit of subglottic pressure is cmH20.
EAT-10 questionnaire
Time frame: At one day before surgery, two months after surgery, six months after surgery
The EAT-10 questionnaire consists of a 10-item questionnaire with a maximum total score of 40 points. All items are rated on a 5-point scale in which 0 indicates no problem, and 4 indicates a severe problem in swallowing function. An EAT-10 score of over 3 is abnormal and indicates a higher self-perception of the presence of dysphagia.
Swallowing ability to four different textures
Time frame: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
An early 5-point scoring system (score one corresponding to the early postoperative assessment) was applied to each patient depending on his ability to swallow one to four different textures (liquid, semi-liquid, semi-solid, and solid). A score of 0 is poor (no power to swallow), while a score of 4 is good.
2 secondary outcomes
Voice acoustic analysis
Time frame: At one day before surgery, six months after surgery
The time in weeks of nasogastric feeding
Time frame: At two months after surgery, six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 25595047Bagwell K, Leder SB, Sasaki CT. Is partial laryngectomy safe forever? Am J Otolaryngol. 2015 May-Jun;36(3):437-41. doi: 10.1016/j.amjoto.2014.11.005. Epub 2014 Nov 20.
- Background: PubMed 34982204Freitas AS, Santos IC, Furia C, Dornelas R, Silva ACAE, Dias FL, Salles GF. Prevalence and associated factors of aspiration and severe dysphagia in asymptomatic patients in the late period after open partial laryngectomy: a videofluoroscopic evaluation. Eur Arch Otorhinolaryngol. 2022 Jul;279(7):3695-3703. doi: 10.1007/s00405-021-07231-4. Epub 2022 Jan 4.
- Background: PubMed 26853312Breunig C, Benter P, Seidl RO, Coordes A. Predictable swallowing function after open horizontal supraglottic partial laryngectomy. Auris Nasus Larynx. 2016 Dec;43(6):658-65. doi: 10.1016/j.anl.2016.01.003. Epub 2016 Feb 4.
- Background: PubMed 30983563Dawson C, Pracy P, Patterson J, Paleri V. Rehabilitation following open partial laryngeal surgery: key issues and recommendations from the UK evidence based meeting on laryngeal cancer. J Laryngol Otol. 2019 Mar;133(3):177-182. doi: 10.1017/S0022215119000483.
- Background: PubMed 23473519Clarett M, Andreu MF, Salvati IG, Donnianni MC, Montes GS, Rodriguez MG. [Effect of subglottic air insufflation on subglottic pressure during swallowing]. Med Intensiva. 2014 Apr;38(3):133-9. doi: 10.1016/j.medin.2013.01.003. Epub 2013 Mar 6. Spanish.
- Background: PubMed 32712078Alaskarov E, Ozturk O, Batioglu-Karaaltin A, Gulmez ZD, Erdur ZB, Inan HC. Functional Outcomes of the Hyaluronic Acid Injections in Patients Who Underwent Partial Laryngectomy. J Voice. 2022 May;36(3):417-422. doi: 10.1016/j.jvoice.2020.06.026. Epub 2020 Jul 22.
- Background: PubMed 24100885Fakhry N, Michel J, Giorgi R, Robert D, Lagier A, Santini L, Moreddu E, Puymerail L, Adalian P, Dessi P, Giovanni A. Analysis of swallowing after partial frontolateral laryngectomy with epiglottic reconstruction for glottic cancer. Eur Arch Otorhinolaryngol. 2014 Jul;271(7):2013-20. doi: 10.1007/s00405-013-2750-3. Epub 2013 Oct 8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xujiao Chen, Ms principal investigator
Guangdong Provicial People's Hospital（Guangdong Academy of Sciences), Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open partial horizontal laryngectomy(OPHL), Type I-III and Transoral endoscopic laser cordectomy in people with Laryngeal Cancer and Dysphagia, run by Guangdong Provincial People's Hospital 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pingjiang Ge, M.D. (+8613751753465, gepingjiang@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fiberoptic laryngoscope evaluation of swallowing (time frame: Pre-operation, one week post-operation, two months post-operation, six months post-operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024980, which also lists 7 linked publications.
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 13 Sep 2023.