Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy (SPPDPL)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Enrolling

Conditions: Laryngeal Cancer; Dysphagia

Treatments: Procedure: Transoral endoscopic laser cordectomy; Procedure: Open partial horizontal laryngectomy(OPHL), Type I-III

Study type: Interventional

Funder types: Other

Identifiers

NCT06024980

2022-59 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Supraglottic and glottic T2 laryngeal carcinoma

Active Comparator group

Description:

The open partial horizontal laryngectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T2

Treatment:

Procedure: Open partial horizontal laryngectomy(OPHL), Type I-III

Supraglottic and glottic T1 laryngeal carcinoma

Active Comparator group

Description:

The transoral endoscopic laser cordectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T1

Treatment:

Procedure: Transoral endoscopic laser cordectomy