Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

NCT ID: NCT06024980

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2025-12-01

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.

Conditions

Laryngeal Cancer; Dysphagia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Supraglottic and glottic T2 laryngeal carcinoma

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Supraglottic and glottic T1 laryngeal carcinoma

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

Group Type: ACTIVE_COMPARATOR

Transoral endoscopic laser cordectomy

Intervention Type: PROCEDURE

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).

Interventions

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

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.

Intervention Type: PROCEDURE

Transoral endoscopic laser cordectomy

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).

Intervention Type: PROCEDURE

Other Intervention Names

Type I OPHLs(formerly defined horizontal supraglottic laryngectomy), Type II (previously called supracricoid laryngectomy), and Type III (also named supratracheal laryngectomy).; Transoral carbon dioxide(CO2) laser microsurgery

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xujiao Chen, Ms

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provicial People's Hospital（Guangdong Academy of Sciences), Southern Medical University

Locations

Guangdong Provincial People's hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pingjiang Ge, M.D.

Role: CONTACT

gepingjiang@aliyun.com

+8613751753465

Facility Contacts

Pingjiang Ge

Role: primary

gepingjiang@aliyun.com

+8613751753465

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2022-59

Identifier Type: -

Identifier Source: org_study_id