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Partial nephrectomy(PN) and tumor enucleation(TE) are the two main methods of Nephron-sparing surgery for early renal cell carcinoma. Because of its blunt separation, TE is often considered to be difficult to completely remove tumor tissue. In addition, compared with PN, TE is more difficult and has higher professional requirements for surgeons. Therefore most surgeons use PN. But Many studies have shown that TE has advantages over PN such as less trauma, faster recovery, and better protection of renal function without increasing the risk of tumor recurrence.
The main renal artery should be clamped during PN to achieve a relatively bloodless operation environment to ensure the safety of tumor resection. However, too long warm ischemia time will inevitably affect the function of normal renal tissue. Studies have shown that shortening the time of renal ischemia is closely related to the recovery of renal function after the operation. So reducing the time of warm ischemia until zero ischemia has become the pursuit of surgeons. Based on renal cell carcinoma resection combined with zero ischemia technique, renal parenchyma, and renal function can be protected to the maximum extent on the premise of ensuring tumor safety.
The purpose of this study is to explore the safety and efficacy of zero-ischemia TE by analyzing the data of early renal cell carcinoma patients who had undergone PN and zero-ischemia TE before.
According to the inclusion and exclusion criteria,collecting the data of participants who have undergone partial nephrectomy or renal tumor enucleation.
The investigators will compare the difference between TE and PN, clamped-enucleation and unclamped-enucleation, suture and sutureless zero-ischemia enucleation by the data the investigators collected.
After analysing the data, the investigators will discuss the safety and efficay of the sutureless zero-ischemia tumor enucleation. The patient who would be benefited from this operation and the patient who would be suggested to undergo this operation will also be discussed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group PN | The patients undergoing partial nephrectomy. | ||
| Group TE | The patients undergoing renal tumor enucleation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Operation time | Period of surgery |
| Estimated blood loss | The estimated blood loss of operation | Period of surgery |
| Positive rate of incision margin | Positive rate of incision margin | Period of surgery |
| Serum creatinine | Serum creatinine of patients before and after operation and follow-up | Pre-operative, 1 day after the surgery and monthly follow-up in one year |
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Inclusion Criteria:
Exclusion Criteria:
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The patients with early renal carcinoma who have undergone partial nephrectomy or tumor enucleation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yichun Zheng, Doctor | Contact | 0571-87783550 | springworld@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Yichun Zheng, Doctor | The Fourth Affiliated Hospital Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Yiwu | Zhejiang | 322000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35117173 | Result | Wu X, Chen W, Huang J, Zhang J, Liu D, Huang Y, Chen Y, Xue W. Zero ischemia laparoscopic microwave ablation assisted enucleation vs. laparoscopic partial nephrectomy in clinical T1a renal tumor: a randomized clinical trial. Transl Cancer Res. 2020 Jan;9(1):194-202. doi: 10.21037/tcr.2019.12.73. | |
| 41282560 | Derived |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2023 | Feb 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Xu C, Jiang Y, Du J, Yang K, Zhong Q, Liu D, Zhang C, Zheng Y. Three-dimensional reconstruction-guided modified arterial-based complexity scoring system for nephron-sparing surgery: comparative outcomes of on-clamp and off-clamp tumor enucleation in renal cell carcinoma. Front Surg. 2025 Nov 6;12:1683222. doi: 10.3389/fsurg.2025.1683222. eCollection 2025. |
| D009369 | 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 |