UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043969 |
|---|---|
| Receipt number | R000050030 |
| Scientific Title | Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy |
| Date of disclosure of the study information | 2021/04/19 |
| Last modified on | 2026/01/20 14:26:57 |
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Basic information
Public title
Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy
Acronym
Prospective observational study about tissue thickness of bronchus in lung surgery
Scientific Title
Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy
Scientific Title:Acronym
Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy
Region
| Japan |
Condition
Condition
Primary lung cancer
Metastatic lung tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To correct data that will be helpful to establish criteria for the selection of suitable cartridges for bronchial suturing and development of automatic staplers by evaluating the tissue thickness of the lobar bronchial wall and the staple formation of the staple cartridges selected.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between bronchial wall thickness, staple cartridge type, and staple formation
Key secondary outcomes
Correlation between bronchial wall thickness, gender, age, body size, smoking history, and underlying diseases
Correlation between bronchial wall thickness based on CT findings and actual measurement
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for resection of the lower lobe of the right or left lung for primary lung cancer or metastatic lung tumor (including suspected) in our department.
Key exclusion criteria
Patients with central localization or extension of the tumor that makes it difficult to suture the bronchus with an automatic suture in the normal line of dissection.
Patients who have undergone any preoperative treatment.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakao |
Organization
Cancer Institute Hospital, The Japanese Foundation for Cancer Research
Division name
Department of Thoracic Surgical Oncology
Zip code
135-8550
Address
3-10-6 Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
masayuki.nakao@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Nakao |
Organization
Cancer Institute Hospital, The Japanese Foundation for Cancer Research
Division name
Department of Thoracic Surgical Oncology
Zip code
135-8550
Address
3-10-6 Ariake, Koto-ku, Tokyo, Japan
TEL
03-3520-0111
Homepage URL
masayuki.nakao@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, The Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson K.K. Medical Company
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital, The Japanese Foundation for Cancer Research
Address
3-10-6 Ariake, Koto-ku, Tokyo, Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.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
がん研究会有明病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/ases.70225
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/ases.70225
Number of participants that the trial has enrolled
80
Results
Conclusions: Although each cartridge performed well, ensuring tissue apposition and good clinical outcomes, green or black cartridges appeared to be more appropriate than gold for the lower bronchus, especially in men and women > 160 cm in height.
Results date posted
| 2026 | Year | 01 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eighty patients scheduled to undergo right or left lower lobectomy were included. The cohort comprised 43 men and 37 women. The underlying disease was primary lung cancer in 73 patients and metastatic lung tumors in seven patients.
Participant flow
Written informed consent was obtained from all patients, who were prospectively enrolled. Patients who ultimately did not undergo lower lobectomy and those in whom evaluation of the bronchial stump was difficult were excluded.
Adverse events
Pneumonia G5 one
Outcome measures
Staple score of the bronchial stump
Bronchial stump thickness
Incidence of adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items:
Correlation between bronchial wall thickness, staple cartridge type, and staple formation
Correlation between bronchial wall thickness, gender, age, body size, smoking history, and underlying diseases
Correlation between bronchial wall thickness based on CT findings and actual measurement
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050030
