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Trial registered on ANZCTR


Registration number
ACTRN12612000443897
Ethics application status
Approved
Date submitted
5/04/2012
Date registered
18/04/2012
Date last updated
18/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
surgical treatment of laryngeal cancer
Scientific title
Middle frontal horizontal partial laryngectomy(MFHPL): a treatment for Stage T1b squamous cell carcinoma of the glottic larynx involving anterior vocal commissure
Secondary ID [1] 280358 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laryngeal cancer 286231 0
Condition category
Condition code
Cancer 286448 286448 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients of T1b laryngeal cancer involving anterior vocal commissure(AVC) were treated with middle frontal horizontal partial laryngectomy(MFHPL) or anterior frontal vertical partial laryngectomy (AFVPL) .
MFHPL: A window of cartilage was made by cuts from upper 1/3 (about 0.5 cm to the superior aspect of the cartilage) and lower 1/3 (about 0.5 cm to the inferior aspect of the cartilage) in the midline to the middle of the posterior aspects of the cartilage. Larynx was then entered by transecting the intralaryngeal mucosa/muscles through one of the cartilage incisions that was farther from the AVC, based on the anatomical relationship between the AVC and cartilage indicated by CT. The tumor was then resected under direct vision with tumor free margins of over 5 mm. Stitches entered at the upper cartilage lamina and came out at the lower vestibular mucosa, then entered at the lower aspect of thyroid cartilage lamina and came out at the subglottic mucosa. These four stitches were aligned and tied to close the larynx.

AFVPL:The vertical outline was made along the anterior aspect of the thyroid lamina with 3-5 mm deviation towards the less involved side, and approximately 8-12 mm deviation towards the more severely involved side. A vertical incision was made with a saw on bilateral thyroid laminas. The laryngeal cavity was visualized and approached through the less involved side. The true and false cords interior to the frontolateral thyroid cartilage were resected along with subglottic soft tissues, with tumor margins of over 5 mm. Depending on the extent of the laryngeal defects, the laryngeal cavity was closed directly or reconstructed using sternohyoid myofascia (single or double pedicles), or sternohyoid perichondrium.

Both AFVPL and MFHPL are about 1 and a half hours procedure, performed once only.

The postoperative complications, voice quality and survival rates were evaluated and compared .
Intervention code [1] 284636 0
Treatment: Surgery
Comparator / control treatment
Some Patients of T1b laryngeal cancer involving AVC were treated with AFVPL as comparator .
Control group
Active

Outcomes
Primary outcome [1] 286979 0
Maximum phonation time (MPT): MPT was evaluated in all patients 6 months post operation. Patients were asked to take one deep breath and then pronounce the vowel / a: / as long as possible at a comfortable pitch and loudness.

The maximum phonation time (MPT) after surgery were 12.42sec in the AFVPL-treated group; while in the MFHPL-treated patients they were 7.65 sec.
Timepoint [1] 286979 0
6 months post surgery
Primary outcome [2] 286980 0
The patients were followed up for tumor recurrence and metastasis.This outcome was assessed by enhance CT, MRI scan and biopsy.

In the MFHPL group, the follow-up time ranged from 15 to 120 months. A total of 20 patients were followed up for more than 3 years and 10 patients for more than 5 years with one patient lost. Tumor local recurrence occurred in four patients (13.3%) with one of them accompanied with neck lymph node metastasis.

In the AFVPL group, all the patients were followed up for 20-130 months. A total of 28 patients were followed up for more than 3 years with 2 patients lost. Tumor local recurrence occurred in 4 patients (15%) with two of them accompanied with neck lymph node metastasis.
Timepoint [2] 286980 0
5 years after operation
Secondary outcome [1] 297057 0
Subcutaneous emphysema(This outcome was assessed by cervical condition of subcutaneouscrepitus).

Three cases were found subcutaneous emphysema in the MFHPL group.
Five cases were found subcutaneous emphysema in the AFVPL group.
Timepoint [1] 297057 0
6 months post surgery
Secondary outcome [2] 297104 0
Aspiration (This outcome was assessed by clinical symptoms of cough when drinking or eating and chest radiograph).


Four cases were found aspiration in the MFHPL group.
Five cases were found aspiration in the AFVPL group.
Timepoint [2] 297104 0
6 months post surgery
Secondary outcome [3] 297105 0
Laryngeal stenosis (This outcome was assessed by clinical symptoms of dyspnea and electrolaryngendoscope )

No case were found laryngeal stenosis in the MFHPL group.
Six cases were found laryngeal stenosis in the AFVPL group.
Timepoint [3] 297105 0
6 months post surgery
Secondary outcome [4] 297106 0
Pneumonia(This outcome was assessed by clinical assessments and chest radiograph).



Two cases were found pneumonia in the MFHPL group.
One case were found pneumonia in the AFVPL group.
Timepoint [4] 297106 0
6 months post surgery
Secondary outcome [5] 297107 0
Laryngeal fistula(This outcome was assessed by clinical assessments and electrolaryngendoscope).


No case was found pneumonia in the MFHPL group.
Two case were found pneumonia in the AFVPL group.
Timepoint [5] 297107 0
6 months post surgery

Eligibility
Key inclusion criteria
Patients with stage T1bN0M0 early glottic carcinoma and anterior commissure involvement were investigated in our studies. All diagnoses were confirmed as squamous carcinoma by biopsies.
Minimum age
45 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with TNM stages other than T1bN0M0 were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation by hospital record number
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients of T1b laryngeal cancer involving AVC would be allocate to MFHPL group for whose hospital record number was odd number. The rest would be allocate to AFVPL group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4240 0
China
State/province [1] 4240 0
Guangdong

Funding & Sponsors
Funding source category [1] 285052 0
Hospital
Name [1] 285052 0
The First Affiliated Hospital of Sun Yat-sen University
Address [1] 285052 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country [1] 285052 0
China
Primary sponsor type
Individual
Name
Lei wenbin
Address
Zhong shan 2nd Road 58,
Guangzhou 510080
Country
China
Secondary sponsor category [1] 283916 0
Individual
Name [1] 283916 0
Su Zhenzhong
Address [1] 283916 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country [1] 283916 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287057 0
Institutional Review Board of the First Affiliated Hospital of Sun Yat-sen University
Ethics committee address [1] 287057 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Ethics committee country [1] 287057 0
China
Date submitted for ethics approval [1] 287057 0
02/02/1996
Approval date [1] 287057 0
15/02/1996
Ethics approval number [1] 287057 0

Summary
Brief summary
The clinical efficiency of current treatments for T1b laryngeal cancer involving AVC is not satisfactory. Clinical trial about MFHPL and AFVPL were carried out to improve the efficiency of these patients. Both MFHPL and AFVPL could treat these patients effectively. however, MFHPL preserved an intact laryngeal framework, decreased the laryngeal wound, reduced the occurrence of laryngeal stenosis and improved the voice quality post surgery.The postoperative complications, glottic reconstruction, recurrence rate, voice quality and survival rates were evaluated and compared between two treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34023 0
Address 34023 0
Country 34023 0
Phone 34023 0
Fax 34023 0
Email 34023 0
Contact person for public queries
Name 17270 0
Lei wenbin
Address 17270 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 17270 0
China
Phone 17270 0
0086-20-87333733
Fax 17270 0
0086-20-87333733
Email 17270 0
leiwb2003@yahoo.com.cn
Contact person for scientific queries
Name 8198 0
Lei wenbin
Address 8198 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 8198 0
China
Phone 8198 0
0086-20-87333733
Fax 8198 0
0086-20-87333733
Email 8198 0
leiwb2003@yahoo.com.cn

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary