cancer of the renal pelvis and ureter upper tract urothelial carcinoma
Conditions
Interventions
Surgery:
Open or robot-assisted radical nephroureterectomy according to department
standard.
Procedure:
Robot /laparoscopic - assisted nephroureterectomy:
A 12-mm camera port is placed at the level
this
port is moved farther laterally in morbidly obese patients to allow for the
instruments to reach the target organs. Three 8-mm robotic trocars are placed
under direct vision and a 12-mm assist
Research Triangle Park, NC) is placed around
the ureter to prevent tumor from traveling down the ureter during manipulation.
The ureter is swept upward off of the psoas muscle and followed superiorly
lymphadenectomy
renal pelvis
ureter
urothelial carcinoma
Sponsors
Zealand University Hospital
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: -written informed consent -age >17 years -Eastern Cooperative Oncology Group (ECOG) performance status 0-2;All patients need at least one criterium of A and one of B. A. Histological defined upper tract urothelial carcinoma (UTUC): histologically confirmed diagnosis of predominantly urothelial carcinoma of the upper tract. 1. Positive biopsy for high grade tumor 2. Selective upper tract positive cytology 3. Micturition positive cytology (if there is no bladder cancer simultaneously);B. Radiological defined UTUC: patients with UTUC cT2-T4, N0-M0 (TNM classification). Criteria must be defined by radiologists;Pelvic of calyx tumor: 1. Absence of fat between pelvis and kidney 2. Evidence of parenchymal invasion 3. Growing of tumour out of the renal pelvis 4. Tumor >1 cm;Upper 2/3 of ureter: 1. growing of the tumour out of the ureter 2. dilation grade 3-4 3. tumor >1 cm
Exclusion criteria
Exclusion criteria: -Clinical suspicion of non-muscle invasive UTUC -Metastatic urothelial carcinoma for the renal pelvis or upper 2/3 of the ureter -Radiological positive lymph nodes in the retroperitoneal region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint/analysis: Recurrence free survival at five-year postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Incidence of lymph node metastases, local recurrence and/or distant metastasis, cancer specific and overall survival at one, three and five-year postoperative. Complications rate according to Clavien classification within the first thirty days postoperatively [9]. Another endpoint/analysis: Multivariate analysis of possible preoperative risk factors for lymph node metastases (tumor size, preoperative urinary cytology, lymph node enlargement on CT, PET-CT positive) and postoperative risk factors for lymph node metastases (stage, grade, tumor diameter, presence of necrosis in the tumor (none; 10% of total tumor area), number of lymph nodes excised). | — |
Countries
The Netherlands
Outcome results
None listed