Un-blinded Multicenter Study to Assess the Safety and Efficacy of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Renal Cell Carcinoma Patients

Un-blinded Multicenter Study to Assess the Safety and Efficacy of Robotic-assisted (da Vinci surgical system, DVSS) Laparoscopic Partial Nephrectomy for Renal Cell Carcinoma Patients - Un-blinded Multicenter Study of Robotic-assisted Laparoscopic Partial Nephrectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013964

Enrollment

100

Registered

2014-05-15

Start date

2014-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cT1 Renal Canser

Interventions

Laparoscopic partial nephrectomy using da Vinci surgical system (DVSS)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)cT1 renal cell carcinoma clinically diagnosed by contrast enhanced CT abdomen scan (if the patient is unable to take the contrast agent, MRI will be performed), and a partial nephrectomy is able to be performed. (slice of contrast enhanced CT abdomen must be <1 cm) 2)detecting no metastasis of lymph node or intra-abdominal organ by contrast enhanced CT abdomen scan (if the patient is unable to take the contrast agent, MRI will be performed) (cN0,cM0). 3)detecting no metastasis by the contrast enhanced CT chest scan or bone scintigraphy. 4)single tumor 5) -WBC > 3000/microL -Plt >= 10x10^4/microL -AST =< 100 IU/L -ALT =< 100 IU/L -Total Bilirubin =< 2.0 mg/dL -Serum creatinine =< 2.0 mg/dL Tested within 6 weeks(42 days)prior to enrollment. 6)>= 20 years of age at the informed consent. 7)written informed consent is obtained.

Exclusion criteria

Exclusion criteria: 1)multiple cancer 2)history of kidney transplantation. 3)therapies for renal cell cancer in the past 6 months. 4)unable to withdrawal of anticoagulation 5)anemia or hemorrhagic tendency requiring transfusion 6)obesity(Body Mass Index:BMI>=35) 7)dialysis patient. 8)pregnant, suspected of being pregnant, or lactating woman. 9)difficult to participate the study due to psychiatric disorder or psychological symptom. 10)inappropriate by the investigator or sub-investigator at the hospital (site) for any other reasons.

Design outcomes

Primary

Measure	Time frame
Preservation of renal function and radical resection of renal cell carcinoma (negative surgical margin and ischemic time <25min.)	—

Secondary

Measure	Time frame
-Surgical time -Console time -Intraoperative blood loss -Renal function (eGFR) -Complete rate of the robotic-assisted laparoscopic partial nephrectomy -Conversion to open surgery or laparoscopic surgery -Postoperative recovery process (the date of first intraoral intake, postoperative hospital stay) -Overall survival period -Recurrence-free survival time -Perioperative (during and early postoperative) adverse events (urine leakage, hemorrhage, etc.) -Postoperative adverse events -Late postoperative adverse events (cardiac, cerebrovascular diseases) -Mechanical defects	—

Measure

Time frame

-Surgical time -Console time -Intraoperative blood loss -Renal function (eGFR) -Complete rate of the robotic-assisted laparoscopic partial nephrectomy -Conversion to open surgery or laparoscopic surgery -Postoperative recovery process (the date of first intraoral intake, postoperative hospital stay) -Overall survival period -Recurrence-free survival time -Perioperative (during and early postoperative) adverse events (urine leakage, hemorrhage, etc.) -Postoperative adverse events -Late postoperative adverse events (cardiac, cerebrovascular diseases) -Mechanical defects

—

Countries

Japan

Contacts

Public ContactKazushi Tanaka

Kobe University Graduate School of Medicine Division of Urology, Department of Surgery Related

uro6155@med.kobe-u.ac.jp078-382-6155

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026