UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012485 |
|---|---|
| Receipt number | R000014472 |
| Scientific Title | The significance of second-look procedure of transoral videolaryngoscopic surgery (TOVS) |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2021/08/30 13:10:33 |
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Basic information
Public title
The significance of second-look procedure of transoral videolaryngoscopic surgery (TOVS)
Acronym
Second-look procedure of TOVS
Scientific Title
The significance of second-look procedure of transoral videolaryngoscopic surgery (TOVS)
Scientific Title:Acronym
Second-look procedure of TOVS
Region
| Japan |
Condition
Condition
Oropharyngeal carcinoma, Hypopharyngeal carcinoma, Laryngeal carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The assessment of the complete resection in the first TOVS by the second-look prucedure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Existence or non-existence of the remnant tumor at the second-look procedure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Complete resection and negative surgical margin by pathological examination (follow-up group)
Interventions/Control_2
Incomplete resection and/or positive surgical margin by pathological examination (second-look procedure group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Oropharyngeal carcinoma, hypopharyngeal carcinoma and laryngeal carcinoma patients who will be resected the primary tumor by TOVS.
Key exclusion criteria
Refused cases for second-look procedure
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Oridate |
Organization
Yokohama City University School of Medicine
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2685
noridate@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Goshi |
| Middle name | |
| Last name | Nishimura |
Organization
Yokohama City University School of Medicine
Division name
Otorhinolaryngology, Head and Neck Surgery
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2687
Homepage URL
gnishimu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University School of Medicine, Departoment of Otorhinolaryngology, Head and Neck Surgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
045-787-2930
onodera@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1002/cam4.2588
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/cam4.2588
Number of participants that the trial has enrolled
51
Results
The study enrolled 26 and 25 patients in the control and intervention group, respectively. The success rate for single resection was 66% and the predictive factor was tumor depth obtained by enhanced computed tomography (CT) examination (odds ratio, 7.870, p=0.0243). The success rate for definitive therapy by TOS alone was 83% and the predictive factor was poor differentiation observed on pathological examination (odds ratio, 6.800, p=0.0248).
Results date posted
| 2019 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Early T-stage laryngeal, oropharyngeal and hypopharyngeal cancer patients were enrolled.
Participant flow
Within these patients, those who were able to treat by transoral surgery were analysed.
Adverse events
No.
Outcome measures
The success rate for single resection was 66% and the predictive factor was tumor depth obtained by enhanced computed tomography (CT) examination (odds ratio, 7.870, p=0.0243). The success rate for definitive therapy by TOS alone was 83% and the predictive factor was poor differentiation observed on pathological examination (odds ratio, 6.800, p=0.0248).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 04 | Day |
Last modified on
| 2021 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014472
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