Lymph Node Dissection
Conditions
Keywords
urothelial cancer, nephroureterectomy, Upper urinary tract
Brief summary
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.
Interventions
PROCEDURERoutine Template-based lymphadenectomy
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.
PROCEDURELND only for lymph nodes enlargement found in preoperative image or during surgery
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
Sponsors
Peking University First Hospital
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* clinically diagnosed with upper tract urothelial carcinoma * have no distant metastasis * have an Eastern Cooperative Oncology Group (ECOG) score 0 to 2 * expected to receive radical nephroureterectomy
Exclusion criteria
* a prior history of bladder cancer * administration of neoadjuvant chemotherapy * deny to receive long term follow-up * patients with contralateral UTUCs * patients with synchronous muscle invasive bladder cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 36 month | Disease free survival rate in the 36 month following nephroureterectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer specific survival | 36 month | Cancer specific survival rate in the 36 month following nephroureterectomy |
| Overall survival | 36 month | Overall survival rate in the 36 month following nephroureterectomy |
| The recurrence rate of bladder cancer in the 36 month following nephroureterectomy | 36 month | The recurrence rate of bladder cancer in the 36 month following nephroureterectomy |
| Perioperative complications rate | 90 day | Perioperative complications were evaluated up to 90 days after surgery, and were graded by Clavien-Dindo classification |
Countries
China
Contacts
Primary Contactjiwei huang, M.D.
Outcome results
None listed