Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

NCT06024980 | Unknown

• 1 other identifier: 2022-59
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngeal Cancer; Dysphagia

Keywords

partial laryngectomy; subglottic pressure; laser

Outcome Measures

Primary Outcomes (4)

• 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

  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.

  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.

  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.

  At one day before surgery, one week after surgery, two months after surgery, six months after surgery

Secondary Outcomes (2)

• Voice acoustic analysis

  At one day before surgery, six months after surgery

• The time in weeks of nasogastric feeding

  At two months after surgery, six months after surgery

Study Arms (2)

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

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

Procedure: Transoral endoscopic laser cordectomy

Interventions

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

Also known as: Type I OPHLs(formerly defined horizontal supraglottic laryngectomy), Type II (previously called supracricoid laryngectomy), and Type III (also named supratracheal laryngectomy).

Supraglottic and glottic T2 laryngeal carcinoma

Transoral endoscopic laser cordectomy 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).

Also known as: Transoral carbon dioxide(CO2) laser microsurgery

Supraglottic and glottic T1 laryngeal carcinoma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 25595047 BACKGROUND

• 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.

  PMID: 34982204 BACKGROUND

• 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.

  PMID: 26853312 BACKGROUND

• 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.

  PMID: 30983563 BACKGROUND

• 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.

  PMID: 23473519 BACKGROUND

• 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.

  PMID: 32712078 BACKGROUND

• 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.

  PMID: 24100885 BACKGROUND

MeSH Terms

Conditions

Laryngeal Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases

Study Officials

• Xujiao Chen, Ms

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pingjiang Ge, M.D.

CONTACT

+8613751753465; gepingjiang@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 6, 2023
• Study Start: January 3, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)