For Donor:small renal tumors For Recipient:End stage chronic renal failure
Conditions
Interventions
Surgery,restored kidney transplantation
Sponsors
Tokushukai Medical Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For Donor: 1.Cases with a small renal tumour,less than 7 cm in diameter, suspected to be a solitary renal cell carcinoma on imaging diagnosis by abdominal echo, thoracoabdominal CT or abdominal MRI, with no other lesions on imaging other than the kidney. 2.Cases in which partial nephrectomy is not indicated for the following reasons. 2.1. renal tumour less than 4 cm, so-called T1a, when partial nephrectomy is considered difficult for the following reasons: 2.1.1. or 2.1.2. or 2.1.3. 2.1.1. with a R.E.N.A.L Nephrometry Score of 10 or more 2.1.2.R.E.N.A.L Nephrometry Score from 4 to 9 with an inward extension of more than 50%. 2.1.3. R.E.N.A.L Nephrometry Score from 4 to 9 with haematuria 2.2. renal tumour greater than 4 cm and less than 7 cm so called T1b cases 3. the patient's age is over 40 years. 4. the appropriateness of nephrectomy is understood prior to the explanation about the study and the patient is willing to undergo nephrectomy. 5. the patient has been informed of the name and condition of the disease. 6. is able to give consent to participate in the study after having been informed in the donor's explanatory and consent documents. For Recipient: 1. The patient is on dialysis treatment but is unable to maintain chronic dialysis treatment and wishes to have a kidney transplant. 2. Willing to undergo transplantation of their own volition and have the cooperation of family, friends, etc. 3. The patient is over 40 years of age. 4. The anaesthesiologist has judged that the patient can undergo surgery under general anaesthesia. 5. The patient has been informed of and understands the advantages and disadvantages of transplanting a repaired kidney and is considered a suitable recipient for a repaired kidney transplant. 6. The patient is able to give consent for renal transplantation after explanation in the explanatory and consent documents for the recipient.
Exclusion criteria
Exclusion criteria: For Donor: 1. Patients who have received anti-cancer drugs (including molecular targeted drugs, cytokines, etc.) or other drugs within one month of nephrectomy. 2. Patients with a history of irradiation of the kidney to be removed. 3. Suspected renal tumours such as malignant lymphoma or sarcoma, or malignant tumours outside the kidney. 4. Comorbid infections (e.g. HIV, HBV, HCV) and serious illnesses. 5. Cases in which partial nephrectomy is deemed appropriate. 6. Cases other than those listed above, where the principal investigator performing the nephrectomy, the ethics review committee of the nephrectomy facility or the restorative renal transplantation review committee considers the case inappropriate as a subject. For Recipient: 1.The patient has an active infection, bleeding ulcer or malignancy. 2. The patient has a severe vascular or circulatory disorder (e.g. aortic aneurysm, cerebral thrombosis, myocardial infarction, thrombosis, pulmonary embolism), which may be exacerbated by transplantation. 3. Patients other than those listed above who are deemed inappropriate for inclusion by the transplant facility's principal investigator, the transplant facility's ethical review committee or the restorative renal transplant review committee.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For Recipient: Renal viability rate from post-renal transplantation to 5 years post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| For Donor and Recipient: occurrence of cancer and patient survival from post-renal transplantation to 5 years post-operatively | — |
Countries
Japan
Contacts
Public ContactJunji Natsuhara
Uwajima Tokushukai Hospital Department of Clinical trial
Outcome results
None listed