Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection
Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection
The primary objective is to show that performing a lymph node dissection may detect occult
 nodal metastasis in this patient population whereby providing important diagnostic
 information, with potential therapeutic benefits in patients with isolated nodal metastases.

 In case of urothelial carcinoma of the upper urinary tract (a cancer originating from the
 inner lining of the urinary tract) requiring the removal of the kidney, ureter, and cuff of
 bladder (a surgical termed a nephroureterectomy). Previous studies in urothelial carcinoma of
 the bladder, have shown that doing a lymph node dissection (surgically removing the lymph
 nodes) may improve survival, or at least give an idea of what patients may need chemotherapy
 (drugs to control the cancer cells that are outside the kidney-ureter) earlier (before the
 nodes are enlarged in the imaging studies).
Participants will have a nephroureterectomy (taking the kidney and the ureter). Investigators
 will also be doing a lymph node dissection (taking the patient's lymph nodes in the same side
 of the kidney) to look for malignancy outside of the kidney and ureter. The lymph nodes will
 be sent to pathology for review.

 Study visits will be scheduled 10 to 14 days after surgery for removal of stitches and
 analysis of the patient's pathology report.

 The following procedures will be done:

 -  History and physical examination, urinary cytology (test to look for malignant cells in
 the urine) and surveillance cystoscopy (procedure to look inside the urethra and bladder
 which is performed in the office under local anesthesia) every 3 months for the first 2
 years after treatment, every 6 months for the next 2 years and yearly thereafter if the
 patient is free from recurrence.

 -  Radiographic studies including chest x-ray and abdomino-pelvic computed tomography (CAT
 scans) will be performed every 6 months for the first 2 years and then yearly
 thereafter.

 -  Bone scan (special imaging study to look for cancer spread in bone) in case of bone pain
 or elevated alkaline phosphatase level.

 After surgery patients will be followed every 3 months for the first 2 years after treatment,
 every 6 months for the next 2 years and yearly thereafter if they are free from recurrence.
Inclusion Criteria:

 -  Patients with suspected transitional cell carcinoma of the upper urinary tract which
 are deemed surgical candidates

 -  Negative visible retroperitoneal or peri-hilar lymphadenopathy on pre-operative
 radiographic studies. Defined as the absence of suspicious abdominal, retroperitoneal,
 or pelvic lymphadenopathy (defined as > 1 centimeter [cm]) on pre-operative
 radiographic imaging (Abdominal and pelvic computed tomography [CT] or magnetic
 resonance imaging [MRI] if CT contraindicated). Imaging studies can be done at Moffitt
 or at a local facility of the patient's choice. All imaging studies are going to be
 reviewed at Moffitt.

 -  Note: Nodal involvement will depend on the size of the lymph node enlargement; usually
 nodes of more than 2 cm are associated with malignancy. With a threshold of 1cm, false
 negative rates for microscopic metastases are low (4%) and false positive rates are
 between 3 to 43% according to the literature. Because the aim of the study will be to
 perform a lymph node dissection in patients with non-metastatic disease based on
 pre-operative evaluation, 1 cm will be the threshold used. Nodes of more than 1 cm
 will be considered positive and those patients will be excluded as is mentioned in the
 protocol. Biopsy will not be included as part of the protocol as those potential
 patients with nodes of more than 1 cm will be excluded.

 -  No other suspected sites of metastasis on pre-operative radiographic imaging

 Exclusion Criteria:

 -  Patients with visible lymph node metastasis on pre-operative radiographic studies.
 Defined as >1cm abdominal, retroperitoneal or pelvic lymphadenopathy

 -  Patients with suspected sites of distant metastasis on pre-operative imaging.
 (Patients with suspected bony metastases will require a bone scan.)

 -  Patients with suspected transitional cell carcinoma of the upper urinary tract with
 significant comorbidities making them non-surgical candidates

 -  Patients with non-transitional cell carcinoma of the upper urinary tract will be
 excluded from this study.