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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
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Recent studies showed the therapeutic benefit of lymphadenectomy in advanced stage urothelial carcinoma of the upper urinary tract, but there is still a lack of prospective studies. Thus, the current guideline recommends lymph node dissection for invasive upper tract urothelial carcinoma (UTUC) on the basis of insufficient evidence. Also, the preoperative judgment of muscle invasive pathological stage T 2+,or N+ is difficult from preoperative imaging. In the investigators' clinical practice, the surgeons performed dissection of regional lymph nodes only in patients with enlargement of lymph nodes found in preoperative imaging or during surgery. The aim of this multi-institutional study was to examine the role of lymphadenectomy in urothelial carcinoma of the upper urinary tract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine lymph node dissection (LND) during nephroureterectomy | Experimental | Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue. |
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| LND for lymph nodes enlargement found before or during surgery | Active Comparator | LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Template-based lymphadenectomy | Procedure | Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled "en bloc" with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Disease free survival rate in the 36 month following nephroureterectomy | 36 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer specific survival | Cancer specific survival rate in the 36 month following nephroureterectomy | 36 month |
| Overall survival | Overall survival rate in the 36 month following nephroureterectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jiwei huang, M.D. | Contact | 8613651682825 | huangjiwei@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Xue, M.D | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Principal Investigator |
| Liqun Zhou, M.D | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijin | Beijin | 100034 | China |
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| LND only for lymph nodes enlargement found in preoperative image or during surgery | Procedure | LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery |
|
| 36 month |
| The recurrence rate of bladder cancer in the 36 month following nephroureterectomy | The recurrence rate of bladder cancer in the 36 month following nephroureterectomy | 36 month |
| Perioperative complications rate | Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification | 90 day |
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200123 | China |
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