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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.
Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microwave enucleation | Experimental | zero ischemia laparoscopic microwave ablation-assisted enucleation of the tumor |
|
| laparoscopic partial nephrectomy | Active Comparator | conventional laparoscopic partial nephrectomy with clamping of the renal artery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic microwave ablation-assisted enucleation | Procedure |
| ||
| conventional laparoscopic partial nephrectomy |
| Measure | Description | Time Frame |
|---|---|---|
| absolute change in glomerular filtration rate (GFR) of the affected kidney | measured by renal scintigraphy | baseline, 3 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| absolute change in eGFR of the affected kidney | baseline, 3 months, 6 months and 12 months | |
| absolute change in total GFR | measured by renal scintigraphy | baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Ran Huang, M.D. | RenJi Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Shanghai | Shanghai Municipality | 200127 | China |
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| Procedure |
|
| blood loss | during surgery |
| operation time | during surgery |
| surgical margin | assessed according to the pathology report of the operation specimen | 1 month |
| postoperative complications | number of participants with postoperative complications graded by Clavien- Dindo system | up to 6 months |
| progression-free survival | 12 months |
| local recurrence | 12 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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