Un-blinded Multicenter Study of Robotic-assisted Laparoscopic Partial Nephrectomy

JRCT ID: jRCT1052190004

Registered date:04/04/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: cT1 Renal Cancer
• Date of first enrollment: 02/09/2014
• Target sample size: 100
• Countries of recruitment: none
• Study type: Interventional
• Intervention(s): Laparoscopic partial nephrectomy using da Vinci surgical system (DVSS)

Outcome(s)

• Primary Outcome: Preservation of renal function and radical resection of renal cell carcinoma (negative surgical margin and ischemic time <25min.)

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)Tested within 6 weeks (42 days) prior to enrollment.
-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
6)>= 20 years of age at the informed consent.
7)written informed consent is obtained.

Exclude 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

Related Information

• Primary Sponsor: Masato Fujisawa
• Secondary ID(s): UMIN000013964