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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy

39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy

Nephron sparing minimally invasive surgery

laparoscopic partial nephrectomy

Completely removal of kidney by using laparoscopic surgery

Laparoscopic radical nephrectomy

Ender Ozden, Prof.

Saban Sarıkaya, Prof.

Mehmet Mercimek, MD, FEBU

Yakup Bostancı, Prof.

Murat Gulsen, MD

The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.

From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.

LPN in Patients With High-complex Renal Tumors

Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis

The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy

abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up

serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)

presence or absence of tumors at the surgical margin

evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages

Presence or absence of local and/or distal tumor recurrence

Ondokuz Mayıs University

Samsun Liv Hospital

Principal Investigator

Radical nephrectomy will be used to remove a cT1a renal mass in an altruistic kidney donor. The kidney obtained from the radical nephrectomy participant with the cT1a mass removed will be transplanted to the recipient using an allograft.

Donor participants will undergo laparoscopic radical nephrectomy (RN) . Donor kidney then will undergo cold perfusion and ex-vivo partial nephrectomy (PN) with cold ischemia. During PN, careful inspection of tumor will be performed to ensure it is well-encapsulated. If any infiltrative features (versus well encapsulated tumor) are noted intraoperatively then transplant will not be performed. Multiple surgical margins will be sent (either frozen section or standard with priority). If final margins are positive or concerning, then transplant will not be performed. Biopsies of the tumor will be performed and sent to pathology (either frozen section or standard with priority).

Donor Radical and Partial Nephrectomy

The donor kidney will remain on ice while pathologic analysis is performed, and transplant recipient surgery is initiated (if pathologic analysis satisfactory). Cold ischemia with delay for pathology will have minimal functional impact in this setting based on extensive prior experience with renal transplantation where kidneys are routinely kept hypothermic for several hours prior to transplantation.

Kidney Transplantation

Radical nephrectomy consists of the removal of the kidney together with the perirenal fat and regional lymph nodes. The transperitoneal approach allows early control of the renal vessels.

Laparoscopic Radical Nephrectomy

Mohamed Eltemamy, MD

This study is designed to investigate a novel approach to offer more ESRD participants the benefits associated with renal transplantation by increasing the supply of available allografts

Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy

Oncologic, Functional and Surgical Outcomes for Patients Undergoing Radical Nephrectomy for Low-Risk Renal Cell Carcinoma and Recipients of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy

Safety and feasibility as determined by peri-operative adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 30 days of surgery:

i. Anemia ii. Acute kidney injury

Safety and feasibility as determined by peri-operative adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 30 days of surgery:

i. Anemia ii. Renal hemorrhage iii. Kidney anastomotic leak iv. Urinary fistula

a. Intermediate term surgical outcomes as determined by adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 180 days of surgery: i. Anemia ii. Acute kidney injury iii. Wound infection iv. Infection and infestations - Urinary tract infection, abscess

Renal function as determined by:

i. Post-operative baseline GFR \>45 ml/min/1.73m2 at time of follow up ii. GFR \>45 ml/min/1.73m2 at one year after radical nephrectomy

c. Oncologic outcomes as determined by local or distant recurrence of malignancy within one year of follow up

Intermediate term surgical outcomes as determined by adverse events of the following Grade 3-5 CTCAE v5.0 outcomes within 180 days of surgery:

i. Anemia ii. Renal hemorrhage iii. Kidney anastomotic leak iv. Urinary fistula v. Wound infection vi. Infection and infestations - Other, Urinary tract infection, abscess, bacteremia

Renal function as determined by:

i. Delayed-graft function ii. Nadir post-transplant GFR iii. GFR measured at one year follow up

c. Oncologic outcomes as determined by local or distant recurrence of malignancy within one year of follow up, diagnosed by one year follow up CT imaging or other method used to determine presence of recurrent malignancy

Participant attitudes and decision making surrounding altruistic donation as a component of surgery for a renal mass will be determined by a survey provided to participants at a preoperative visit prior to surgery and at the 12 month follow-up visit.

Participant attitudes and decision-making surrounding receipt of a kidney that previously had a small renal mass will be determined by a survey provided to participants at a preoperative visit prior to surgery and at the 12-month follow-up visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LPN in Patients With High-complex Renal Tumors	NCT04933604	Renal Cancer Renal Neoplasm Renal Cell Carc... Surgery Oncology Kidney Ischemia Kidney Injury Urologic Neopla... Urologic Cancer Kidney Neoplasm...	laparoscopic pa... Laparoscopic ra...	18 Years - 80 Years	Samsun Liv Hospital
Transplantation of Reconstructed Renal Allografts Following Ex-Vivo Partial Nephrectomy	NCT05725421	Renal Cell Carc...	Donor Radical a... Kidney Transpla... Laparoscopic Ra...	60 Years -	Case Comprehensive Cancer Center
LPN in Patients With High-complex Renal Tumors	NCT04933604	Renal Cancer Renal Neoplasm Renal Cell Carc... Surgery Oncology Kidney Ischemia Kidney Injury Urologic Neopla... Urologic Cancer Kidney Neoplasm...	laparoscopic pa... Laparoscopic ra...	18 Years - 80 Years	Samsun Liv Hospital
LPN in Patients With High-complex Renal Tumors	NCT04933604	Renal Cancer Renal Neoplasm Renal Cell Carc... Surgery Oncology Kidney Ischemia Kidney Injury Urologic Neopla... Urologic Cancer Kidney Neoplasm...	laparoscopic pa... Laparoscopic ra...	18 Years - 80 Years	Samsun Liv Hospital
LPN in Patients With High-complex Renal Tumors	NCT04933604	Renal Cancer Renal Neoplasm Renal Cell Carc... Surgery Oncology Kidney Ischemia Kidney Injury Urologic Neopla... Urologic Cancer Kidney Neoplasm...	laparoscopic pa... Laparoscopic ra...	18 Years - 80 Years	Samsun Liv Hospital

Spots Global Cancer Trial Database for laparoscopic radical nephrectomy