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

Primary Purpose

Laryngeal Cancer, Dysphagia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Open partial horizontal laryngectomy(OPHL), Type I-III
Transoral endoscopic laser cordectomy
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laryngeal Cancer focused on measuring partial laryngectomy, subglottic pressure, laser

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Guangdong Provincial People's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Supraglottic and glottic T2 laryngeal carcinoma

Supraglottic and glottic T1 laryngeal carcinoma

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Voice acoustic analysis
Every participant was asked to phonate a sustained vowel /a/ at a habitual comfortable pitch and intensity for voice pitch, quality assessments, and habitual vocal intensity. The recordings were made in a quiet clinical room. The participant sat in front of a microphone positioned approximately 10cm from the left corner of the mouth. The voice signal coupled with Roland's Audio interface with a sampling rate of 44k-Hz and 16-bit accuracy. The signal was stored in a computer system after collecting sustained vowels. The voice signals were analyzed using speech analysis software. The stable phase of the voice sample was extracted for analysis. The 3,000-msec sample was analyzed for acoustic parameters. The voice acoustic parameters include F0 (fundamental frequency) in Hertz(Hz), percentage of jitter(%), percentage of shimmer(%), Harmonic to noise ratio(HNR), and intensity in decibels(dB).
The time in weeks of nasogastric feeding
The duration of surgery to oral feeding after withdrawing naso tube.

Full Information

First Posted
August 21, 2023
Last Updated
September 8, 2023
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06024980
Brief Title
Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy
Acronym
SPPDPL
Official Title
Department of Otolaryngology Head Neck Surg
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Cancer, Dysphagia
Keywords
partial laryngectomy, subglottic pressure, laser

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supraglottic and glottic T2 laryngeal carcinoma
Arm Type
Active Comparator
Arm Description
The open partial horizontal laryngectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T2
Arm Title
Supraglottic and glottic T1 laryngeal carcinoma
Arm Type
Active Comparator
Arm Description
The transoral endoscopic laser cordectomy was underwent in patients with supraglottic or glottic laryngeal carcinoma in T1
Intervention Type
Procedure
Intervention Name(s)
Open partial horizontal laryngectomy(OPHL), Type I-III
Other Intervention Name(s)
Type I OPHLs(formerly defined horizontal supraglottic laryngectomy), Type II (previously called supracricoid laryngectomy), and Type III (also named supratracheal laryngectomy).
Intervention Description
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
Intervention Name(s)
Transoral endoscopic laser cordectomy
Other Intervention Name(s)
Transoral carbon dioxide(CO2) laser microsurgery
Intervention Description
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).
Primary Outcome Measure Information:
Title
Fiberoptic laryngoscope evaluation of swallowing
Description
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
Time Frame
Pre-operation, one week post-operation, two months post-operation, six months post-operation
Title
direct subglottic pressure
Description
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.
Time Frame
At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Title
EAT-10 questionnaire
Description
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.
Time Frame
At one day before surgery, two months after surgery, six months after surgery
Title
Swallowing ability to four different textures
Description
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.
Time Frame
At one day before surgery, one week after surgery, two months after surgery, six months after surgery
Secondary Outcome Measure Information:
Title
Voice acoustic analysis
Description
Every participant was asked to phonate a sustained vowel /a/ at a habitual comfortable pitch and intensity for voice pitch, quality assessments, and habitual vocal intensity. The recordings were made in a quiet clinical room. The participant sat in front of a microphone positioned approximately 10cm from the left corner of the mouth. The voice signal coupled with Roland's Audio interface with a sampling rate of 44k-Hz and 16-bit accuracy. The signal was stored in a computer system after collecting sustained vowels. The voice signals were analyzed using speech analysis software. The stable phase of the voice sample was extracted for analysis. The 3,000-msec sample was analyzed for acoustic parameters. The voice acoustic parameters include F0 (fundamental frequency) in Hertz(Hz), percentage of jitter(%), percentage of shimmer(%), Harmonic to noise ratio(HNR), and intensity in decibels(dB).
Time Frame
At one day before surgery, six months after surgery
Title
The time in weeks of nasogastric feeding
Description
The duration of surgery to oral feeding after withdrawing naso tube.
Time Frame
At two months after surgery, six months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pingjiang Ge, M.D.
Phone
+8613751753465
Email
gepingjiang@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xujiao Chen, Ms
Organizational Affiliation
Guangdong Provicial People's Hospital(Guangdong Academy of Sciences), Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pingjiang Ge
Phone
+8613751753465
Email
gepingjiang@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25595047
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.
Results Reference
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34982204
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.
Results Reference
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PubMed Identifier
26853312
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.
Results Reference
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PubMed Identifier
30983563
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.
Results Reference
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PubMed Identifier
23473519
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.
Results Reference
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PubMed Identifier
32712078
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.
Results Reference
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PubMed Identifier
24100885
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.
Results Reference
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Using the Subglottic Pressure to Predict the Dysphagia After Partial Laryngectomy

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