UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051556 |
|---|---|
| Receipt number | R000058822 |
| Scientific Title | Machine Learning Approach to Predict Tracheal Necrosis after Total Pharyngolaryngectomy and Free Jejunal Transfer |
| Date of disclosure of the study information | 2023/07/08 |
| Last modified on | 2023/07/08 22:01:45 |
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Basic information
Public title
Machine Learning Approach to Predict Tracheal Necrosis after Total Pharyngolaryngectomy and Free Jejunal Transfer
Acronym
Machine Learning Approach to Predict Tracheal Necrosis after Total Pharyngolaryngectomy and Free Jejunal Transfer
Scientific Title
Machine Learning Approach to Predict Tracheal Necrosis after Total Pharyngolaryngectomy and Free Jejunal Transfer
Scientific Title:Acronym
Machine Learning Approach to Predict Tracheal Necrosis after Total Pharyngolaryngectomy and Free Jejunal Transfer
Region
| Japan |
Condition
Condition
All patients underwent TPL and FJT for biopsy-proven squamous cell carcinoma (SCC) at our institution from April 2010 to April 2023 were included. Exclusion criteria were: (1) patients underwent TPL and FJT for non-SCC, (2) patients underwent TPL and FJT in conjunction with total esophagectomy and (3) patients with prior history of total esophagectomy.
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is to identify risk factors for tracheal necrosis after TPL and FJT without total esophagectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint was the incidence of tracheal necrosis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | years-old | <= |
Age-upper limit
| 200 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients underwent TPL and FJT for biopsy-proven squamous cell carcinoma (SCC) at our institution from April 2010 to April 2023 were included.
Key exclusion criteria
Exclusion criteria were: (1) patients underwent TPL and FJT for non-SCC, (2) patients underwent TPL and FJT in conjunction with total esophagectomy and (3) patients with prior history of total esophagectomy.
Target sample size
395
Research contact person
Name of lead principal investigator
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East, Kashiwa, Japan
Division name
Department of Plastic and Reconstructive Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL
+81-4-7133-1111
tahidaka1986@gmail.com
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Hidaka |
Organization
National Cancer Center Hospital East, Kashiwa, Japan
Division name
Department of Plastic and Reconstructive Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL
81471331111
Homepage URL
tahidaka1986@gmail.com
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery,
National Cancer Center Hospital East
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Institute
Department
Personal name
Funding Source
Organization
None.
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
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Tel
+81-4-7133-1111
tahidaka1986@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
395
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint was the incidence of tracheal necrosis. Tracheal necrosis was defined as the necrotic lesion of the cartilage or the pars membranacea of more than one tracheal ring1 developed during the postoperative hospitalization period and required any medical treatments including ointment application.
Tracheostoma stenosis is one of the most important sequelae of tracheal necrosis. We define tracheostoma stenosis as the condition requiring tracheal stenting with a T-tube within postoperative six months, and investigated its incidence in the patients developed tracheal necrosis.
As treatment of tracheal necrosis can be time-consuming, hospitalization period was compared between the groups with and without tracheal necrosis.
Management information
Registered date
| 2023 | Year | 07 | Month | 08 | Day |
Last modified on
| 2023 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058822
