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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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To evaluate the feasibility and efficiency of zero ischemia laparoscopic radio frequency ablation assisted enucleation of T1a renal cell carcinoma in comparison with the conventional laparoscopic partial nephrectomy.
Warm ischemic injury is one of the most important factors affecting renal function in partial nephrectomy (PN). Zero ischemia partial nephrectomy technique using renal arterial branch microdissection could protect renal function during surgery, but it requires longer operative time and more blood loss than conventional partial nephrectomy. The technique of zero ischemia laparoscopic radio frequency ablation assisted enucleation of renal cell carcinoma appears to be an alternative that eliminates warm ischemia, preserves the maximal parenchyma and is oncologically safe. Our study was designed to evaluate this technique in comparison with the conventional laparoscopic partial nephrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zero ischemia 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. |
|
| conventional laparoscopic partial nephrectomy | Active Comparator | Renal hilum will be accurately isolated and then the artery only will be clamped during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zero ischemia laparoscopic RFA assisted TE | Procedure |
|
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| Measure | Description | Time Frame |
|---|---|---|
| the absolute change in glomerular filtration rate (GFR) of the affected kidney | 12 months minus baseline | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| estimated GFR (eGFR) | 12 months | |
| changes in GFR of total kidneys by renal scintigraphyby | baseline and 12 months | |
| blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiran Huang, M.D. | Contact | 86-13501835219 | yrhuangrenji@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yiran Huang, M.D. | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RenJi Hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26905020 | Derived | Huang J, Zhang J, Wang Y, Kong W, Xue W, Liu D, Chen Y, Huang Y. Comparing Zero Ischemia Laparoscopic Radio Frequency Ablation Assisted Tumor Enucleation and Laparoscopic Partial Nephrectomy for Clinical T1a Renal Tumor: A Randomized Clinical Trial. J Urol. 2016 Jun;195(6):1677-83. doi: 10.1016/j.juro.2015.12.115. Epub 2016 Feb 22. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ischemia | Procedure | conventional laparoscopic partial nephrectomy |
|
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| during surgery |
| surgical margin | pathologic confirm of surgical margin | postoperative |
| postoperative complications | 12 months |
| progression-free survival | 12 months |
| local recurrence | 12 months |
| the absolute change in glomerular filtration rate (GFR) of the affected kidney | 6 months minus baseline | baseline and 6 months |
| estimated GFR (eGFR) of 6 month | 6 month |
| changes in GFR of total kidneys by renal scintigraphyby of 6 month | 6 month |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |