UMIN-CTR Clinical Trial

Basic information
Public title	Study for efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection using da Vinci surgical system
Acronym	Efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection
Scientific Title	Study for efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection using da Vinci surgical system
Scientific Title:Acronym	Efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection
Region	Japan

Condition
Condition	Mediastinal tumor
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Operative time, blood loss, perioperative complications, histopathological findings, and postoperative outcome will be evaluated for assessment of efficacy and safety of robot-assisted thoracoscopic mediastinal tumor resection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Operative time, blood loss, perioperative complications, histopathological findings, and postoperative outcome
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Mediastinal tumor resection will be performed by robot-assisted thoracoscopic surgery using da Vinci surgical 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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	5cm or smaller sized mediastinal tumor diagnosed by CT scan No obvious invasion to adjacent organ Informed consent obtained from the patient
Key exclusion criteria	Severe cardiac disorders Severe pulmonary disorders Impossible cessation of anticoagulants Severe obesity (BMI>35) Patients without informed consent Any other reasons considered as inappropriate for this study
Target sample size	5

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hisashi Suzuki
Organization	Ibaraki Prefectural Central Hospital
Division name	Department of Thoracic Surgery
Zip code
Address	6528, Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL	0296-77-1121
Email	hsuzuki-jpn@umin.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hisashi Suzuki
Organization	Ibaraki Prefectural Central Hospital
Division name	Department of Thoracic Surgery
Zip code
Address	6528, Koibuchi, Kasama, Ibaraki 309-1793, Japan
TEL	0296-77-1121
Homepage URL
Email	hsuzuki-jpn@umin.ac.jp

Sponsor
Institute	Ibaraki Prefectural Central Hospital
Institute
Department

Funding Source
Organization	Ibaraki Prefectural Central Hospital
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
Address
Tel
Email

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	2016 Year 05 Month 09 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
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	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 30 Day
Date of IRB	2015 Year 04 Month 22 Day
Anticipated trial start date	2016 Year 05 Month 09 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 05 Month 02 Day
Last modified on	2019 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025544