UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022146
Receipt number R000025387
Scientific Title Examination for the acquisition of the facility criterion of laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery)
Date of disclosure of the study information 2016/05/02
Last modified on 2016/04/30 11:20:37

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Basic information

Public title

Examination for the acquisition of the facility criterion of laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery)

Acronym

Examination for the acquisition of the facility criterion of Da Vinci partial nephrectomy for renal cell carcinoma

Scientific Title

Examination for the acquisition of the facility criterion of laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery)

Scientific Title:Acronym

Examination for the acquisition of the facility criterion of Da Vinci partial nephrectomy for renal cell carcinoma

Region

Japan


Condition

Condition

renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

In the medical fee revision at 2016 April, laparoscopic surgery for renal malignant tumor (using supportive equipment for endoscopic surgery) was approved. Because full-time physician with the medical treatment of the experience more than 10 cases of as facility criterion is required, we perform the Da Vinci partial nephrectomy of 10 cases in our school expenses.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

radical resection
renal function

Key secondary outcomes

ischemic time
estimated blood loss
console time
operating time
complication


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

Maneuver

Interventions/Control_1

After the surgery, we follow-up 4 weeks.

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

18 years-old <

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients diagnosed with renal cell carcinoma cT1a, cN0, cM0.
Patients obtained the consent in writing.

Key exclusion criteria

Patients with a previous treatment of ipsilateral partial nephrectomy.
Patients with severe heart or respiratory failure.
Patients with severe renal dysfunction.
Patients who physician has determined to be ineligible.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidehiro Kakizaki

Organization

Asahikawa Medical College

Division name

Renal and Urologic Surgery

Zip code


Address

Midorigaoka higashi 2-1-1-1 asahikawa hokkaido Japan

TEL

0166-68-2533

Email

gtamajp@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Gaku Tamaki

Organization

Asahikawa Medical College

Division name

Renal and Urologic Surgery

Zip code


Address

Midorigaoka higashi 2-1-1-1 asahikawa hokkaido Japan

TEL

0166-68-2533

Homepage URL


Email

gtamajp@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical College

Institute

Department

Personal name



Funding Source

Organization

Asahikawa Medical College

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


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 02 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

Preinitiation

Date of protocol fixation

2016 Year 04 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 30 Day

Last modified on

2016 Year 04 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025387


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name