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| Name | Class |
|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Changzheng Hospital | OTHER |
| Changhai Hospital | OTHER |
| Shanghai 6th People's Hospital |
Zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation has been proved to enable tumor excision with relatively better renal function preservation comparing with conventional laparoscopic partial nephrectomy for T1a renal cell carcinoma (RCC) in a randomized clinical trial in single center. The investigators want to explore this technique to T1 RCC patients in randomized clinical trial in multiple centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero Ischemia group | Experimental | Radiofrequency ablation(RFA) /Microwave ablation(MVA) will be performed for 1 to 4 cycles each depending on tumor size and depth. The tumor then will be laparoscopic enucleation without hilar clamping in most cases. |
|
| Conventional group | 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 |
|---|---|---|---|---|
| conventional laparoscopic partial nephrectomy | Procedure | renal artery will be clamped during surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the change in glomerular ļ¬ltration rate (GFR) of the affected kidney | Baseline and 30 months | |
| changes of estimated GFR (eGFR) | Baseline and 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| estimated blood loss | during surgery | |
| rates of positive surgical margin | postoperativeļ¼up to 2 weeks after surgery | |
| postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiwei huang, M.D. | Contact | 862168383776 | jiweihuang@outlook.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | 200127 | China |
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| OTHER |
| Fudan University | OTHER |
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| zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE) | Procedure |
|
| postoperativeļ¼up to 30 days |
| the rate of local recurrence | through study completion, an average of 3 years |
| operative time | During surgery |
| Hospital stay time | The time from the surgery day to patient discharge, up to 2 weeks |
| progression-free survival rate | through study completion, an average of 3 years |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| 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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