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To evaluate the feasibility and efļ¬ciency of zero ischemia robot-assisted laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with robot-assisted laparoscopic partial nephrectomy without hilar clamping.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted laparoscopic RFA assisted TE | Experimental | RFA will be performed for 1 to 4 cycles for 4 to 12 minutes each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping. |
|
| Robot-Assisted laparoscopic partial nephrectomy | Active Comparator | The tumor then will be laparoscopic enucleation without hilar clamping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zero ischemia robot-assisted laparoscopic RFA assisted TE | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change in glomerular ļ¬ltration rate (GFR) of the aļ¬ected kidney | 12 months minus baseline | baseline and 12 months |
| The changes of estimated GFR (eGFR) | 12 months minus baseline | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| estimated blood loss | during surgery | |
| changes in GFR of total kidneys by renal scintigraphyby | baseline and 12 months | |
| surgical margin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Zhang, PhD. | Contact | +8618801967501 | rjxuyunze@163.com | |
| Yiran Huang, MD. | Contact | +8613501835219 | huangyrrenji@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ethics Committee of Shanghai Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| zero ischemia robot-assisted laparoscopic partial nephrectomy | Procedure |
|
|
| postoperativeļ¼up to 2 weeks after surgery |
| postoperative complications | postoperativeļ¼up to 30 days |
| progression-free survival | 12 months |
| local recurrence | 12 months |
| operative time | During surgery |
| Hospital stay time | The time from the surgery day to patient discharge, up to 2 weeks |
| changes in GFR of total kidneys by renal scintigraphyby of 6 month | baseline and 6 months |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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