Group (A) [study cases] Adult patients who will undergo radical or partial nephrectomy.for primary renal cell carcinoma.

Group (B) [control cases] Adult patients who will undergo simple nephrectomy for benign causes

Renal Cell Carcinoma

Histopathological study and evaluation:
For each case, the tissue samples will be evaluated by the pathologist for detecting the histopathology and in cases of malignant renal spicemens the pathologist will also assess the histologic type, Fuhrman nuclear grade, cellular invasion of perinephric fat, and the extent of any vascular invasion seen by microscopy.
Immunohistochemistry:
Immunohistochemical staining will be performed by using the following antibodies: Geminin and Minichromosome maintenance-2 (MCM-2).
Evaluation of the immunohistochemical staining will be performed by light microscopy. The interpretation of immuno-reactivity will be performed in a quantitative manner by analyzing the extent of the staining positivity of the tumor cells. Immuno-staining of greater than 10% of tumor cells is required for scoring as a positive case.

Immunohistochemistry

Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma

Role of Immunohistochemical Markers , Geminin and Mcm2 in Prognosis of Renal Cell Carcinoma, and Its Clinicopathological Correlation. A Prospective Controlled Study

Number of patients that develops recurrent tumor after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

Number of patients that develops tumor metastasis after partial or radical nephrectomy as diagnosed by Multi slice CT will be assessed

Mohamed Abdelghany Allam

Assistant lecturer

Assiut University

2 groups : Group A include cases and Group B includes controls

Patients receive recombinant EphB4-HSA fusion protein IV over 60 minutes once weekly for 3 weeks (3 doses) in the absence of disease progression or unacceptable toxicity. Patients who agree may receive the fourth dose after an additional week as determined by the study medical oncologist. Two to four weeks after the last dose of recombinant EphB4-HSA fusion protein, patients undergo robotic-assisted radical cystectomy or robotic-assisted radical or partial nephrectomy.

Infiltrating Bladder Urothelial Carcinoma

Recurrent Bladder Carcinoma

Stage I Prostate Cancer

Stage I Renal Cell Cancer

Stage II Bladder Urothelial Carcinoma

Stage II Renal Cell Cancer

Stage IIA Prostate Cancer

Stage IIB Prostate Cancer

Stage III Prostate Cancer

Stage III Renal Cell Cancer

Cytology Specimen Collection Procedure

Laboratory Biomarker Analysis

Undergo robotic-assisted radical cystectomy

Radical Cystectomy

Recombinant EphB4-HSA Fusion Protein

Undergo robotic-assisted radical or partial nephrectomy

Therapeutic Conventional Surgery

USC / Norris Comprehensive Cancer Center

sEphB4-HSA Before Surgery in Treating Patients With Bladder Cancer, Prostate Cancer, or Kidney Cancer

A Pilot Study of Neoadjuvant sEphB4-HSA in Patients With Genitourinary Cancers

Feasibility is defined for the purpose of this study as >= 90% of patients completing at least 3 doses of drug therapy without DLTs and are able to undergo minimally-invasive surgery as planned.

All observed adverse events and complications will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity, and time of onset. Tables will be created to summarize these adverse events and complications, overall, by disease cohort, and by phase (neoadjuvant, during surgery, within 30 days post‐operative, and days 31‐90 post‐operative).

Pathologic response rates will be calculated and 90% confidence intervals will be constructed.

Radiologic response rates will be calculated and 90% confidence intervals will be constructed.

University of Southern California

National Cancer Institute (NCI)

The laser tissue welding device is intended for use in patients requiring laparoscopic surgery requiring hemostasis and sealing of the resected kidney after partial nephrectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure.
The device's intended use is to seal the kidney surface using a laser to weld human albumin based biomaterials after surgical removal of kidney tumors during a laparoscopic partial nephrectomy.

Benign Renal Tumors

Malignant Renal Tumors

Laparoscopic partial nephrectomy will be robotically assisted using the second generation da Vinci® Surgical System. Once the tumor is resected with laparoscopic scissors with a margin of healthy tissue, the solder will be dripped onto the cut surface of the parenchyma. A laparoscopic rigid 5mm spot-size laser hand-piece will be passed through the 10-mm port. The diode laser will be then used to weld a thin layer of solder onto the cut parenchymal surface. The 60 Watt 810-nm diode laser will be set to deliver continuous energy. During soldering, the tip of the laparoscopic laser hand-piece will be maintained 1 to 2 cm from the renal surface to generate a spot size of approximately 5 mm. Each spot will be treated with the laser until the color of the solder changes from green to white. The renal pedicle clamp will be removed to allow renal blood supply to be restored and the surgical site inspected for evidence of bleeding for 10 minutes prior to completing the surgical procedure.

Laser Tissue Welding Device

5R44DK094619-02 NIH Fast Track Small Business Innovative Research Grant

St. Luke's Episcopal Hospital

First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy

Phase-I Feasibility Trial To Study The Safety Of Laser Tissue Welding For Sealing Resected Kidney Surfaces After Laparoscopic Partial Nephrectomy

Operative blood loss is defined by: Volume of blood in the suction bottles, volume of blood clots, and weight of surgical towels before and after use.
Clinical assessment of the blood loss: Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemo-dilution. Therefore is correlated with blood products transfused to compensate for the blood lost during surgery.

Clinical assessment of the blood loss:
Clinical drop in hemoglobin (1 gm. % = 300 ml) without hemodilution. Therefore is correlated with blood products transfused to compensate for the blood lost post-operatively.
Correlated to post-operative JP tube drainage, amount and type.

Post-operative blood loss requiring return to the operating room

Urinary leakage is measured in drainage bottles (ml/day) following surgery till a drain placed during the operation is removed before patient discharge. Accumulation of fluids around the kidney (blood or urine) will be assessed with U/S and CT scan at the mentioned time points.

To see if the protein solder is a nidus for stone formation

Observed intra-operatively. Assesses organ ischemia time and will correlate with compromised renal function post-surgery.

Observed intra-operatively:
Cumulative time to complete hemostasis. This will be compared to current standard of care time-to-hemostasis using suture closure which is anywhere between 15 and 45 minutes since a major renal reconstruction is required with suturing and therefore correlated to significant clamp time, renal ischemia and renal dysfunction.

kidney neoplasms/ألبيومين

Role of Geminin and Mcm-2 in Prognosis of Renal Cell Carcinoma

sEphB4-HSA Before Surgery in Treating Patients With Bladder Cancer, Prostate Cancer, or Kidney Cancer

First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy

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