Clinical trial NCT06024980: Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy
Official title: Department of Otolaryngology Head Neck Surg
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laryngeal Cancer
Dysphagia
Keywords: partial laryngectomy
subglottic pressure
laser
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fiberoptic laryngoscope evaluation of swallowing
timeFrame: Pre-operation, one week post-operation, two months post-operation, six months post-operation
measure: direct subglottic pressure
timeFrame: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
measure: EAT-10 questionnaire
timeFrame: At one day before surgery, two months after surgery, six months after surgery
measure: Swallowing ability to four different textures
timeFrame: At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Secondary outcomes:
measure: Voice acoustic analysis
timeFrame: At one day before surgery, six months after surgery
measure: The time in weeks of nasogastric feeding
timeFrame: At two months after surgery, six months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provicial People's Hospital（Guangdong Academy of Sciences), Southern Medical University
name: Xujiao Chen, Ms
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Freitas 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.
citation: Breunig 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.
citation: Dawson 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.
citation: Clarett 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.
citation: Alaskarov 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.
citation: Fakhry 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.