Renal Cell Carcinoma
Conditions
Interventions
Study group:bench nephronsparing surgery with kidney autotransplantation
Control group:radical nephrectomy
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: conform to 1~4 and with one of 5~10 (1) Localized renal cell carcinoma (cT1~T2N0M0); (2) Age 18~80 years old, male or female; (3) Good health condition with ECOG score 1~2 or Karnofsky score > 40; (4) Patients or agents agreements and signed informed consents; (5) R.E.N.A.L. score >=10, high risks of bleeding, urinary fistula, positive incision margin, hot ischemia time > 40 min by partial nephrectomy, high ratio of radical nephrectomy; (6) Totally ingrowing RCC; (7) RCC located in renal hilum or renal sinus; (8) Multiple RCC in single kidney (more than 3); (9) cT1b~T2 cystic renal carcinoma; (10) cT2 RCC with anatomical or functional solitary kidney, chronic renal disease, familial RCC, bilateral RCC, unilateral RCC with renal insufficiency, young patient, with diseases result in chronic renal insufficiency, with strong willing of kidney reserve.
Exclusion criteria
Exclusion criteria: (1) Renal cell carcinoma beyond cT3 or with LN metastasis (N1)/distal metastasis (M1); (2) Unable to perform kidney autotransplantation due to the vascular calcification or atherosclerosis of the tumorous kidney; (3) Unable to perform nephrectomy or kidney autotransplantation due to the intestinal disease or surgery history of abdominopelvic cavity; (4) History of anti-carcinoma therapy 6 months before enrollment such as systemic chemotherapy, targeting therapy or immuno-therapy; (5) With severe infection disease such as bacteremia or sepsis; (6) With renal insufficiency (GFR 2.5 times or Bil > 1.5 times); (9) With severe systemic disease which may cause renal insufficiency such as uncontrolled DM and HBP; (10) With other malignancies treated less than 2 years; (11) Pregnant or lactating female; (12) Participate in other clinical trials at the same period; (13) Other situations that unfit for this trial judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| renal function;overall survival;recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE ratio;quality-adjusted life years; | — |
Countries
China
Contacts
Public ContactJiang Haowen
Huashan Hospital Fudan University
Outcome results
None listed