Recurrence Clinical Trial
Official title:
Impact of Lymph Node Dissection in the Management of High-risk Primary Upper Tract Urothelial Carcinoma Patients
This clinical trial is designed to evaluate the role of lymph node dissection in the prevention of recurrence and metastasis after radical nephroureterectomy for high-risk primary upper tract urothelial carcinoma (UTUC) patients.
INTRODUCTION Upper tract urothelial carcinomas (UTUC) are relatively uncommon compared to
bladder cancer and account for only 5-10% of urothelial carcinomas, with an estimated annual
incidence in Western countries of
~2 cases per 100,000 inhabitants. The therapeutic role of regional lymph node dissection
(LND) for patients with UTUC remains undetermined. Most reports have supported its staging
benefit in which patients with no lymph node metastases (pN0) and those with pathological
node metastasis (pN+) are stratified from those without LND (pNx). However, the therapeutic
benefit of LND remains controversial. This discrepancy might be attributed to two factors.
First, there remains a lack of standardization in the extent of LND. Kondo T et al and Matin
SF et al previously reported the primary sites of lymphatic metastases from a mapping study,
and then determined the anatomical extent of regional lymph nodes. Second, all results
reported so far have been, to the best of our knowledge, derived from retrospective studies.
Thus, the current guideline recommends LND for invasive UTUC on the basis of insufficient
evidence. AIM OF THE WORK This clinical trial is designed to evaluate the role of lymph node
dissection in the prevention of recurrence and metastasis after radical nephroureterectomy
for high-risk primary upper tract urothelial carcinoma (UTUC) patients. PATIENTS AND METHODS
Patients Type of the study: A randomized controlled trial (RCT), phase II. Study locality:
Department of Urology, Peking University First Hospital. Institute of Urology, Peking
University. National Urological Cancer Center, Beijing, China. Study design: Patients who was
ready to receive nephroureterectomy for high-risk primary UTUC will be prospectively
randomized into two groups using excel software by random table function. I. Group 1: will
receive LND during radical nephroureterectomy. II. Group 2: do not receive LND during
surgery.
Inclusion Criteria:
I. Suspected high-risk UTUC patients without metastases in their preoperative radiological
imaging (cN0M0).II. Suspected high-risk UTUC patients without history of bladder tumor.
III. Suspected high-risk UTUC patients without synchronous bladder tumor. IV. Suspected
high-risk UTUC patients without contralateral UTUCs.
Exclusion criteria:
I. Patients with significant metastases in their preoperative radiological imaging.
II. Patients with history of bladder tumor. III. Patients with synchronous bladder tumor. IV.
Patients with contralateral UTUCs. V. Patients with advanced stage (T4). VI. Patients with
other malignant tumors. Methods Intervention Patients who sign an informed consent for
agreement to participate will be randomly allocated into one of the two groups using excel
software by random table function at the day of nephroureterectomy. In group 1, patients will
receive LND during radical nephroureterectomy. While for patients in group 2, no LND will be
received. All data will be prospectively maintained and include patients' demographics,
preoperative laboratory parameters, operative details and postoperative complications Follow
up The scheduled follow up will be according to the EAU guidelines (Rouprêt et al., 2015) by
scheduling a urine cytology and cystoscopy at 3 months then yearly while CT urography every
year for non-invasive tumors and every 6 months over 2 years and then yearly for invasive
tumors. All chemotherapy-related complications will be reported. Outcome and end-point The
primary outcome of the study is to determine the overall survival (OS). The secondary outcome
is to determine the adverse events postoperative morbidity, mortality and other survival
(RFS, CSS, EFS) of patients with high-risk UTUC.
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