UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trials on safety of mediastinal tumor resection by Da Vinci surgery system.
Title of the study (Brief title)	Mediastinal tumor resection by Da Vinci surgery system.
Region	Japan

Condition
Condition	Resectable mediastinal tumor.
Classification by specialty	Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess the safety of robot assisted mediastinal tumor resection using Da Vinci surgery system in clinical trials.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of postoperative adverse events.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Robot assisted mediastinal tumor resection with da Vinci surgery system.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Complete resectable mediastinal tumor (thymoma, neurogenic tumor, congenital cyst, etc.). 2) It is 20 years old to 80 years old. 3) PS (ECOG) is 0 or 1. 4) There is no history of thoracotomy or high degree of adhesion is not expected in the thoracic cavity. 5) It satisfies all the conditions below. (The latest inspection value within 28 days from the registration date is used for all inspection items.) - White blood cell count is 3,000 / mm3 or more. - Platelet count is 100,000 / mm3 or more. - AST is 100 IU / L or less / ALT is 100 IU / L or less. - Total bilirubin is 2.0 g / dl or less. - Serum creatinine is 1.5 mg / dl or more. 6) For patient participation, written consent has been obtained from the patient himself.
Key exclusion criteria	1) Possible pregnancy or lactating women. 2) Psychosis or psychiatric symptoms are merged, and it is judged that participation in the examination is difficult. 3) Continuous systemic administration (ingestion or intravenous) of steroid drugs. 4) I have a history of myocardial infarction within 6 months or unstable angina. 5) Hypertension with poor control is complicated. 6) Diabetes mellitus with poor control. 7) Combined respiratory diseases requiring sustained oxygen therapy. 8) Other cases that the doctor in charge judged inappropriate.
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuhito Funai
Organization	Hamamatsu University School of Medicine.
Division name	First department of surgery.
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan.
TEL	053-435-2276
Email	kfunai@hama-med.ac.jp

Public contact
Name of contact person	Akikazu Kawase
Organization	Hamamatsu University School of Medicine.
Division name	First department of surgery.
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan.
TEL	053-435-2276
Homepage URL
Email	akawase@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine.
Institute
Department

Funding Source
Organization	Hamamatsu University School of Medicine.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 22 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 22 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 22 Day
Last modified on	2018 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031445