Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

Last updated: September 8, 2023
Sponsor: Guangdong Provincial People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head And Neck Cancer

Heartburn

Oral Cancer

Treatment

Transoral endoscopic laser cordectomy

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

Clinical Study ID

NCT06024980
2022-59
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18-80 years
  • Surgical treatment by open partial horizontal laryngectomy type I or II and transorallaser cordectomy for squamous cell carcinoma
  • Availability of clinical data
  • Validity of normal swallowing of thin liquids

Exclusion

Exclusion Criteria:

  • Presence of severe chronic obstructive pulmonary disease, severe heart disease, andpsychopathy or mental disease
  • Surgery complications(such as sepsis, pharyngocutaneous fistula, surgical revision)
  • Radiotherapy histology
  • Swallowing disorder or trachea aspiration before surgery.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Transoral endoscopic laser cordectomy
Phase:
Study Start date:
January 03, 2023
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Guangdong Provincial People's hospital

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

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