臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 04, 2025
Last modified on	Oct. 29, 2026
Trial ID	jRCT1071250065

Scientific Title	A comparative study to examine the effect of mannitol administration during partial nephrectomy on preserving renal function
Public Title	A study to examine the efficacy of mannitol in partial nephrectomy

Contact for Scientific Queries	Name	Ohba Kojiro
	Affiliation	Nagasaki University Hospital
	Address	Sakamoto 1-7-1, Nagasaki city, Nagasaki
	Telephone	+81-958197340
	E-mail	ohba-k@nagasaki-u.ac.jp
Contact for Public Queries	Name	Ohba Kojiro
	Affiliation	Nagasaki University Hospital
	Address	Sakamoto 1-7-1, Nagasaki city, Nagasaki
	Telephone	+81-958197340
	E-mail	ohba-k@nagasaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 04, 2025
Target sample size		44
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1 planned pertial nephrectomy for RCC 2 planned renal scintigram 3 preoperative eGFR 45=< 4 informed consent has been obteined 5 age 18=<
	Exclusion Criteria	1 with contralateral nephrectomy or solitary kidney 2 clinical stage 2=< 3 acute intracranial hematoma
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Renal cell carcinoma
Intervention(s)		Patients will be randomly divided into two groups , with or without mannitol injection before and after clamp. Mannitol is administrated intravenously in 100ml over 3-10minutes under the direction of an anesthesiologist.
Health Condition(s) Code		D002292
Primary Outcome(s)		Postoperative renal function preservation rate on the resected side
Secondary Outcome(s)		4weeks or 24 weeks postoperative total renal function

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Nagasaki University Hospital Clinical Research Review Com mittee
Address	Sakamoto 1-7-1, Nagasaki city, Nagasaki, Nagasaki
Telephone	+81-95-819-7229
E-Mail	gaibushikin@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 04, 2025

Plan to share IPD	Yes
Plan description	When registering research subjects in this study, they will be assigned an identification number for research purposes. The identification number will consist of numbers and symbols that are unrelated to information that can identify a specific individual, such as initials or medical record IDs, and will be used when preparing documents related to this study, such as eligibility confirmation/case registration forms and case reports, and when handling information used in the study. The principal investigator will create a research subject identification table containing information such as the research subject's name and medical record ID so that the research subject can be identified as necessary from the information to which the identification number has been assigned, and will store and manage this information securely to prevent it from being leaked to outside parties.

Plan to share IPD

Yes

Plan description

When registering research subjects in this study, they will be assigned an identification number for research purposes. The identification number will consist of numbers and symbols that are unrelated to information that can identify a specific individual, such as initials or medical record IDs, and will be used when preparing documents related to this study, such as eligibility confirmation/case registration forms and case reports, and when handling information used in the study. The principal investigator will create a research subject identification table containing information such as the research subject's name and medical record ID so that the research subject can be identified as necessary from the information to which the identification number has been assigned, and will store and manage this information securely to prevent it from being leaked to outside parties.

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Oct. 29, 2026	(this page)	Changes
1	Sept. 04, 2025	Detail

List of change history