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

A multicenter prospective single-arm study of robot-assisted partial nephrectomy for completely endophytic renal tumors comparing with a historical control treated with traditional laparoscopic partial nephrectomy. - RAPNCET

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052200016
Enrollment
100
Registered
2020-05-22
Start date
2020-07-20
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

completely endophytic renal tumors

Interventions

Sponsors

Chiba Koji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
warm ischemia time and tumor tissue negative

Secondary

MeasureTime frame
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

Contacts

Public ContactNobuyuki Hinata

Hiroshima University Hospital

rapncet@med.kobe-u.ac.jp+81-82-257-5242

Outcome results

None listed

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