臨床研究等提出・公開システム

Japanese

Date of registration	April. 11, 2023
Last modified on	April. 11, 2023
Trial ID	jRCTs052230008

Scientific Title	A multi-center, randomized non-inferiority clinical trial comparing robotic-assisted fluoroscopic-guided with ultrasound-guided renal access for percutaneous nephrolithotomy in supine position.
Public Title	Robot-assisted fluoroscopic-guided renal access for percutaneous nephrolitotomy in supine position.

Contact for Scientific Queries	Name	Yamashita Shimpei
	Affiliation	Wakayama Medical University Hospital
	Address	811-1 Kimiidera, Wakayama City, Wakayama, Japan
	Telephone	+81-9086505031
	E-mail	keito608@wakayama-med.ac.jp
Contact for Public Queries	Name	Yamashita Shimpei
	Affiliation	Wakayama Medical University Hospital
	Address	811-1 Kimiidera, Wakayama City, Wakayama, Japan
	Telephone	+81-73-441-0637
	E-mail	keito608@wakayama-med.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 11, 2023
Actual date of first enrollment
Target sample size		94
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients whose age are between 16 and 80 years old, diagnosed with renal and/or upper ureteral stone at Wakayama Medical Hospital or Nagoya City University Hospital, and planned for percutaneous nephrolithotomy 2) Stones for 15mm and larger in size 3) Patients who were obtained written informed consent - obtained written informed consent from themselves if they are 18 years old and older - obtained written informed consent from themselves and representatives if their age are between 16 and 17 years old
	Exclusion Criteria	A) women with pregnant or its possibility B) having active pyelonephritis C) under anti-platelet/coagulation therapy within 1 week prior surgery D) difficult status for general/lumber anesthesia judged by anesthesiologist E) Best supportive care due to terminal carcinoma
	Age Minimum	16age old over
	Age Maximum	80age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Urolithiasis
Intervention(s)		RAF group (47 cases): Performing renal puncuture by ANT-X assisted fluoroscopic guidance during percutaneous nephrolithotomy. US group (47 cases): Performing renal puncuture by ultrasound guidance during percutaneous nephrolithotomy.
Health Condition(s) Keyword		renal stone
Intervention(s) Keyword		nephrolithotomy, robot assist, fluoroscopic guidance, ultraso und guidance, renal puncture
Health Condition(s) Code		D052878
Intervention(s) Code		D000074642
Primary Outcome(s)		Success rate of single renal puncture
Secondary Outcome(s)		stone free rate, number of renal punctures, renal puncture time, fluoroscopic time and perioperative complications

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	CRB5180004
Address	811-1 Kimiidera, Wakayama City, Wakayama, Japan, Wakayama
Telephone	+81-73-441-0896
E-Mail	wa-rinri@wakayama-med.ac.jp
Approval Status	Approval
Date of approval	Nov. 04, 2022

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none