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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 robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial.
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 robotic surgery and add suture-less technique to T1 RCC patients in randomized clinical trial. This project is based on the previous research and aims to develop an approach of the combination of intraoperative real time contrast-enhanced ultrasonography technology, sutureless technology and the zero ischemia robot-Assisted tumor enucleation of the kidney. By using the real time contrast-enhanced ultrasonography technology, the current shortcomings of the zero ischemia laparoscopic radio frequency ablation assisted tumor enucleation were overcome. The degree of elimination was monitored during surgery to avoid excessive bleeding caused by insufficient ablation during the surgery. Beside, the difficulty of zero ischemia laparoscopic radio frequency ablation is reduced, and doctors can quickly grasp the learning curve of this technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zero Ischemia suture-less group | Experimental | Patients with T1 Stage renal cell carcinoma undergoing Zero Ischemia, Robot-Assisted Microwave Ablation assisted suture-less tumor Enucleation. |
|
| robotic-assisted partial nephrectomy group | Active Comparator | Patients with T1 stage Renal Cell Carcinoma undergoing traditional robotic-assisted partial nephrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero Ischemia Robot-Assisted Laparoscopic Microwave Ablation Assisted suture-less Enucleation | Procedure | Under the visualization of ultrasound contrast imaging through the operative channel, a microwave ablation probe was inserted into the tumor (at the interface between the tumor and kidney, close to the tumor base). The microwave ablation device was used, with a power setting of 70 W for initiating microwave ablation. Depending on the tumor volume and depth, 1-3 ablation cycles were performed, with each cycle lasting 1-3 minutes. After reaching the pseudocapsule of the tumor, a combination of blunt dissection, sharp cutting, and blunt dissection was employed to separate the tumor from the renal parenchyma . The renal artery was not occluded during the procedure.If intraoperative injury to the collecting system is suspected, the collecting system should be sutured normally, while simultaneously suturing the outer layer of renal parenchyma to prevent urine leakage. |
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change in glomerular filtration rate (GFR) of the affected 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 | |
|---|---|---|---|---|
| Jiwei Huang, PhD. | Contact | 02168383204 | huangjiwei@renji.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 | China |
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| robotic-assisted laparoscopic partial nephrectomy | Procedure | robotic-assisted laparoscopic partial nephrectomy |
|
| postoperative up to 2 weeks after surgery |
| postoperative complications | postoperative up 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 3 month | baseline and 3 months |
| 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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