A multicenter prospective single-arm study of robot-assisted partial nephrectomy for completely endophytic renal tumors

JRCT ID: jRCT1052200016

Registered date:22/05/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: completely endophytic renal tumors
• Date of first enrollment: 20/07/2020
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Laparoscopic partial nephrectomy using da vinci surgical system (DVSS)

Outcome(s)

• Primary Outcome: warm ischemia time and tumor tissue negative

Secondary Outcome

1) eGFR (Estimated Glomerular Filtration Rate)
2)Whether all of Trifecta (hereinafter a. To c. ) are satisfied.
a.Tumor tissue negative at the resected margin.
b.180-day eGFR is 90% or more of that before surgery.
c.By 180 days, no pseudoaneurysms with Clavien-Dind o grade 3 or higher, no postoperative ble eding, or urinary fistula.
3)Raito of eGFR multiplied split (%) between pre- and post-operation by renal scintigraphy in operated kidney.
4)Achieved both tumor tissue negative and warm ischemia time within 25 min.
5)Overall survival
6)Relapse-free survival time
7)Deteriorated CKD free time

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 i n the Tumors without tumor protrusion outward fr om renal cortex, 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 b e less than 5mm
(2) The tumor is less than 7cm (cT1)
(3) Detecting no metastasis of lymph node or intr a-abdominal organ by either contrast enhanced CT abdomen scan or MRI (if the patient is unable t o take the contrast agent). (cN0,cM0)
(4) Detecting no metastasis by the contrast enhan ced CT chest scan or bone scintigraphy. (cM0)
(5) Single tumor
(6) More than 20 years of age at the informed con sent.
(7) Written consent from the individual regarding research participation.

Exclude criteria

(1)Active Multiple cancer
(2)History of kidney transplantation(recipient)
(3)Receiving renal cancer treatment within 6 months from the date of consent for this clinical study.
(4)High risk to general anesthesia
(5)Dialysis patient
(6)Pregnant, suspected of being pregnant, or lactating women.
(7)Judged as an inappropriate patient by the investigator or sub-investigator at the hospital (site) for any other reasons.

Related Information

• Primary Sponsor: Nakano Yuzo
• Source(s) of Monetary Support: Intuitive Surgical Sarl