Un-blinded Multicenter Study to Assess the Safety of RAPN for Hilar Tumors

JRCT ID: jRCT1052190005

Registered date:04/04/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: cT1,cN0,cM0 Hilar Tumors
• Date of first enrollment: 09/02/2017
• Target sample size: 108
• Countries of recruitment: none
• Study type: Interventional
• Intervention(s): Laparoscopic partial nephrectomy using da Vinci surgical system (DVSS)

Outcome(s)

• Primary Outcome: warm ischemia time and margin negative

Secondary Outcome

- Warm ischemia time (within 25 min or not)
- Achieved both margin negative and warm ischemia time (within 25 min)
- Change of pre- and post- operative ERPF (mL/min) in operated kidney
- Change of split (%) multiplied by eGFR in operated kidney
- eGFR
- Overall survival time
- Recurrence-free survival time
- Failure of DVSS
- Adverse Events
- Operative Time
- Console Time
- Blood Loss
- Conversion to open surgery or laparoscopic surgery

Key inclusion & exclusion criteria

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

Include criteria

1) The tumor is diagnosed as the mass located in the renal hilum in contact with a major renal vessels on preoperative imaging, either CT* abdomen scan or MRI (if the patient is unable to take the contrast agent) and an indication for partial nephrectomy.
(*slice of contrast enhanced CT abdomen must be < 5 mm)
2) The tumor is less than 7 cm (cT1)
3) Detecting no metastasis of lymph node or intra-abdominal organ by either contrast enhanced CT*
abdomen scan or MRI (if the patient is unable to take the contrast agent). (cN0, cM0).
4) Detecting no metastasis by the contrast enhanced CT chest scan or bone scintigraphy.
5) Single tumor
6) The subject's laboratory test results within 12 weeks before registration are as follows
- WBC >= 3000/microL
- Plt >= 10 x 10^4/microL
- AST <= 100 IU/L
- ALT <= 100 IU/L
- Total Bilirubin <= 2.0 mg/dL
- Serum creatinine <= 2.0 mg/dL
7) >= 20 years of age at the informed consent.
8) 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) Has a high risk to general anesthesia
5) unable to withdrawal of anticoagulation
6) anemia or hemorrhagic tendency requiring transfusion
7) obesity(Body Mass Index: BMI >= 35)
8) dialysis patient.
9) pregnant, suspected of being pregnant, or lactating woman.
10) difficult to participate the study due to psychiatric disorder or psychological symptom.
11 ) Judged as an inappropriate patient by the investigator or sub-investigator at the hospital (site) for any other reasons.

Related Information

• Primary Sponsor: Masato Fujisawa
• Secondary ID(s): UMIN000023968