UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028133
Receipt number R000032168
Scientific Title Clinical study for Robot-assisted partial nephrectomy with da Vinci Si
Date of disclosure of the study information 2017/08/01
Last modified on 2019/08/14 15:54:26

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Basic information

Public title

Clinical study for Robot-assisted partial nephrectomy with da Vinci Si

Acronym

Clinical study for Robot-assisted partial nephrectomy

Scientific Title

Clinical study for Robot-assisted partial nephrectomy with da Vinci Si

Scientific Title:Acronym

Clinical study for Robot-assisted partial nephrectomy

Region

Japan


Condition

Condition

Renal Cell Carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We examine the effectiveness and safety of Robot-ssited partial nephrectomy using daVinci Si system.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intra-and postoperative complications and its contents

Key secondary outcomes

Time of general anesthesia, operation time, bleeding, renal ischemic time, frequency of postoperative analgesic use, postoperative hospitalization period, perioperative renal function (before surgery (pre-operative surgery 12 weeks before),the day before surgery, on the day of the surgery, the day after surgery, the surgery three days after, the surgery six days later, after one month, three months after surgery)serum creatinine, eGFR), and before surgery (pre-operative surgery 12 weeks before), the day of one month, three months after surgery of renal scintigraphy), pathology findings


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

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

Diagnosed with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors should be performed robot-assited partial nephrectomy under da Vinci SI.

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

1. diagnosed with renal cell carcinoma and the clinical stage T1a (tumors less than 4 cm) N0M0 or T1b (diameter 4 cm to 7 cm), solitary tumors allows partial resection.
2. age of 20 years or more.
3. written informed consent obtained from the individual persons.

Key exclusion criteria

1. the patient seems to be difficult to surgery due to previous surgery.
2. activity of heavy multiple cancer among patients.
3.6 months undergoing treatment for kidney cancer.
4. patients with possible discontinuation of anticoagulants.
5. patients requiring blood transfusion anemia or tendency of bleeding.
6. morbid obesity (BMI35 or higher)
7. kidney transplantation history.
8. dialysis patients.
9. pregnant women or pregnant or lactating women
10. patients with a mental illness or psychiatric symptoms.
11. patients have serious complications (angina pectoris, myocardial infarction, serious arrhythmias, uncontrolled diabetes, malignant hypertension, etc.), surgical treatment is difficult.
12. patients who have renal dysfunction (serum creatinine values:1.5mg/dl more), liver function (AST, ALT:100IU/l).
13. patients with bacterial infections require treatment.
14. patients with interstitial Pneumonitis or pulmonary fibrosis.
15. patients with severe drug hypersensitivity, drug allergies.
16. patients with under 20 years old.
17. patient deemed unfit for this protocol.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Tomoaki
Middle name
Last name Miyagawa

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Urology

Zip code

3308503

Address

1-847, Amanuma-cho, Omiya-ku, Saitama City, Saitama, Japan

TEL

048-647-2111

Email

sh2-mya@jichi.ac.jp


Public contact

Name of contact person

1st name Tomoaki
Middle name
Last name Miyagawa

Organization

Jichi Medical University, Saitama Medical Center

Division name

Department of Urology

Zip code

3308503

Address

1-847, Amanuma-cho, Omiya-ku, Saitama City, Saitama, Japan

TEL

048-647-2111

Homepage URL


Email

sh2-mya@jichi.ac.jp


Sponsor or person

Institute

Jichi Medical University, Saitama Medical Center

Institute

Department

Personal name



Funding Source

Organization

Jichi Medical University, Saitama Medical Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Jichi Medical University Saitama Medical Center

Address

1-847 Amanuma-cho Omiya-ku Saitama City Saitama Japan

Tel

0486472111

Email

sh2-mya@jichi.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



Other administrative information

Date of disclosure of the study information

2017 Year 08 Month 01 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

Enrolling by invitation

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB

2017 Year 06 Month 01 Day

Anticipated trial start date

2017 Year 08 Month 01 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

2017 Year 07 Month 07 Day

Last modified on

2019 Year 08 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name