Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason

Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).

Contrast enhanced ultrasound with Lumason

Jordan Swensson, MD

Marissa Agoston, B.S.

Marissa Agoston

Jordan Swennson, MD

Patients with renal lesions suspicious for renal cell carcinoma (RCC) have a variety of different treatment pathways available to them. Imaging surveillance is being used frequently on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to better guide decision making by urology. This is in large part due to the pathologic grade of renal masses having been shown to correlate with patient outcomes. The World Health Organization (WHO) or Fuhrman grade is the standard grading scale used by pathologists for RCC. The goal of this study will be to correlate contrast enhanced ultrasound findings with the pathologic grade of RCC. Specifically, the investigators hypothesize that tumors with different pathologic grades will show different patterns of qualitative enhancement, as well as different perfusion kinetics.

Renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1 in 83 in women, of which RCC is the most common. RCC comes in a variety of subtypes, and pathologic grade has been shown to be one factor that correlates with patient prognosis \[Novara et al\]. The most commonly used pathologic grading systems are the WHO or Fuhrman scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and nucleolar prominence.

Care of patients with RCC depends on a number of factors, including size and pathologic grade. As such, radiologic surveillance with CT and MRI is common, and percutaneous biopsy of renal masses for the purpose of pathologic grading is also relatively common. While percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still carry risks, especially of hemorrhage give the vascular nature of the kidneys and RCC.

Contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses from normal background renal parenchyma \[Barr et al\]. It has the unique ability to be used in patients with renal dysfunction as it is excreted by the liver and lungs. As such, it is well suited for use in patients with underlying renal pathology. This study will aim to use contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal masses prior to surgical removal, and then evaluate for correlation of these features with pathologic grading following surgery.

Imaging findings for enrolled patients will be compared to pathologic grading

Imaging reviewers will be blinded to pathologic grade

Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS)

Correlation of Contrast Enhanced Ultrasound of Renal Masses With Pathologic Grade: A Prospective Comparison of Quantitative and Qualitative Findings

Ultrasound images will be reviewed for qualitative imaging features as well as quantitative post contrast features (time to peak, area under the curve, mean transit time etc). These findings will then be correlated with the pathologic grade of surgically removed renal masses, to evaluate for differences in imaging features among the different pathologic grades.

Indiana University

Assistant Professor of Clinical Radiology

Coagulants

All Drugs and Chemicals

Hemostatics

Patients undergoing RALPN with the use of HAs by a surgeon.

Patients undergoing RALPN without the use of HAs by a surgeon

Hemostatic agents, if used at all during surgery, will be applied laparoscopically into the tumor bed to stop bleeding. The type of hemostat will be decided by the surgeon according to the anatomy of the tumor bed.

Hemostat

Robert Nadler, MD

The aim of this study is to evaluate whether Hemostatic Agents (HA) make a significant clinical difference in patient outcomes when used for Robotic-Assisted Laparoscopic Partial Nephrectomy (RALPN). The result of this trial will determine whether HAs are necessary for use during RALPN or if they can be omitted from the surgical tools available during this procedure. This study has a direct clinical implication on a patient's outcomes following RALPN, specifically whether patients will have better, worse, or unchanged outcomes with RALPN if HAs are used.

Partial nephrectomy is a surgical procedure wherein a diseased segment of a kidney is surgically removed, leaving behind the remaining healthy kidney parenchyma. This surgical procedure is typically performed to remove mass lesions suspicious for malignancy. A major goal of partial nephrectomy is to spare as much renal function as possible by preserving the healthy portion of the kidney while removing only the pathologic portion of the kidney.

Hemostatic agents (HA) are devices commonly used during robotic-assisted laparoscopic partial nephrectomy (RALPN) due to the risk of bleeding posed by incising a highly vascular organ. The use of various HAs as part of the surgical technique for RALPN is well-described. Potential benefits such as lower blood loss, lower rate of urine leak, and lower blood product transfusion rates have been suggested in small case series. However, larger prospective studies have failed to demonstrate these benefits of HAs. They report similar patient outcomes regardless of HA use. However, these studies are subject to selection bias given the lack of randomization, and they had a small relative number of partial nephrectomies performed without HAs.

To the knowledge of the investigators, no randomized trials have addressed the use of HAs in RALPN. Randomized, controlled trials for partial hepatectomy and knee arthroplasty have shown no benefit when using hemostatic agents to control bleeding.

At the home institution for this study, surgeons routinely use HAs in the resection bed during RALPN. Available, FDA approved, commercial agents include Floseal and Nu-Knit®. Each unit of HA costs $150 - $419 per unit, and often multiple units are used during a given procedure. The hospital is paid a set amount based on the patient's insurance for performing the procedure regardless of use of HA. The use of HAs therefore increases costs incurred by the hospital when performing these procedures. It is imperative to determine if this expenditure is justified.

The primary aim of this study is to compare surgical outcomes in patients undergoing RALPN with and without the use of hemostatic agents. Given the small nature of and conflicting information from the aforementioned cohort studies, it is imperative to remove selection bias and perform a randomized comparison of HA use. This study will provide a much more definitive head-to-head comparison of the overall utility of HAs. Additionally, it may provide more information about differential patient selection for more appropriate and judicious use of HAs. No study has evaluated differential patient selection for HA use, and therefore any finding in this realm would be novel.

The surgical team and the patient will be blinded as to which arm the patient will be assigned both at the time of recruitment in the clinic and at the start of surgery. The patient and surgeon will both be blinded at the start of the surgery (RALPN). The surgeon will be informed intra-operatively during the renorrhaphy portion of the procedure as to which arm the patient will be assigned, at which point he will be un-blinded. Following completion of the entire surgery, the patient will also be informed as to which arm he/she was randomized upon request.

Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

Randomized, Prospective Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy

This will be measured as the difference between the hemoglobin obtained postoperatively (measured at approximately 4 am in the morning after surgery) and the hemoglobin obtained preoperatively in the holding area on the day of surgery.

Major complications are blood loss requiring transfusion of packed red blood cells, reoperation, and endovascular ablation

Incidence of any of the following: urine leak, stroke, cardiac arrest, myocardial infarction, and death.

The number of sutures used during renorrhaphy and capsular closure.

Number of patients in Group 2 (no HA) who required HA at the surgeon's discretion.

Total length of all inpatient hospital stay over 30 days measured in days.

Total charges for all inpatient care over 30 days using billing information recorded in the Northwestern Electronic Data Warehouse.

Northwestern University

Vice Chair, Department of Urology

Technetium Tc 99m Sestamibi

Gopal N Gupta, MD

Agnes Natonton

Hiten D Patel, MD, MPH

The goal of this clinical trial is to better tell apart whether kidney tumors are benign (not cancer) or malignant (cancer) based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor.

The main objectives are:

To estimate and compare the diagnostic accuracy of renal mass biopsy alone, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate malignant and benign renal tumors.

To estimate and compare the diagnostic accuracy of renal mass biopsy, PEER (with renal mass biopsy), and 99mTc-sestamibi SPECT/CT (with renal mass biopsy for hot tumors) to differentiate oncocytoma from chromophobe RCC.

Participants will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study. These can be done on paper, electronically, or by telephone.

The investigators are asking the participant to take part in this research study because they were diagnosed with a kidney tumor. Kidney tumors can be benign (not cancer) or malignant (cancer) and the investigators hope to figure out how to better tell them apart before surgery or other treatment.

The investigators hope to better tell apart whether kidney tumors are benign (not cancer) or malignant (cancer) based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor.

Biopsy is a standard test to determine if a tumor is cancerous before making a treatment decision.

The imaging test (99mTc-sestamibi SPECT/CT) the investigators are studying has been studied before and found to help identify benign kidney tumors. It is not approved by the Food and Drug Administration (FDA) for imaging kidney tumors. It is FDA approved for use in imaging the heart and breasts. It has been studied for use in parathyroid gland imaging.

The participant will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study. The participant will receive a 99mTc-sestamibi SPECT/CT scan (if they have not had one already) for research purposes. The participant will receive a biopsy of the kidney tumor (if they have not had one already) as part of their routine clinical care. The participant will then receive treatment of the kidney tumor as determined by consultation with their doctor.

Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors

A Prospective Diagnostic Cohort Study to Compare the Accuracy of Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors

The classification of each tumor as malignant or benign by the diagnostic approaches of interest will be compared to the primary endpoint of malignant vs. benign based on surgical pathology or biopsy.

The classification of each tumor as RCC or oncocytoma by the diagnostic approaches of interest will be compared to the primary endpoint of RCC vs. oncocytoma based on surgical pathology or biopsy.

To estimate the non-diagnostic rate of renal mass biopsy.

To describe patient-reported measures/outcomes related to mental health, physical health, distress, and regret for the diagnosis and management of renal tumors.

Loyola University

Affiliate Assistant Professor

Symptoms and General Pathology

Ischemia

involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.

involves cases of laparoscopic partial nephrectomy with thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed

Suture renorrhaphy will be used in 2 layers; medullary and cortical, with Vicry 2/0 or 3/0 and secured with V-lock. Early unclamping will be done after hemostasis of the medullary layer. Renorrhaphy of the cortical layer will be continued after that.

Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy

A 2-μm continuous thulium laser with 365 μm laser fiber at 30-40 W will be used for coagulation of the tumor bed. Large vessels that may not be completely sealed with thulium beam will be closed by V-lock to achieve safe and stable hemostasis. Early unclamping will be done after hemostasis of the tumor bed. Suture renorrhaphy will be used in 1 layer to approximate the renal parenchyma.

Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy

Ehab Atallah, A. Lecturer

Hesham AboZied, Professor

Malakah Mohammed, Secretary

Aly Abdel-Karim, Professor

Abdel-Rahman Ebeid, Professor

To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.

To date, no studies have compared the outcomes of thulium beam coagulation versus suture renorrhaphy for hemostasis of tumor bed in laparoscopic partial nephrectomy in patients with small renal messes (SRMs).

This study aims to compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy.

The investigators hypothesize that:

Conducted well designed, randomized prospective comparative study can help to identify which technique is better.

Using thulium beam coagulation for hemostasis of the tumor bed in laparoscopic partial nephrectomy can improve the outcome, shorten intraoperative ischemia time and decrease blood loss.

A randomized prospective comparative study. Two-arm parallel assignment:

First Arm: involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.

Second Arm: involves cases of laparoscopic partial nephrectomy using thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed.

Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy

Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy: Prospective Randomized Comparative Study

Patient data sheet, patient consent forms through my e-mail: Ehab44ehab@gmail.com

Started once renal artery clamped before tumor enucleation till release of the clamp after 1st layer renorraphy in group 1 or Thulium beam coagulation in group 2

Suture time starts from the first suture to the last one, including time of manipulating needles.

which is the count of each time the needle comes out from the renal parenchyma.

Blood loss will be calculated from the suction jar minus the amount of fluid irrigation

Amount of blood in ml transfused intraoperative or postoperative

will be estimated by serum creatinine. Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function

ill be estimated by estimated GFR (eGFR) using Modification of Diet in Renal Disease (MDRD) equation (Levey et al., 2006).

Chronic kidney disease (CKD): will be staged according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines to reflect the change of renal function

will be measured in urine to indicate the fibrogenic process that occurs in renal parenchyma after PN

from time of surgery till time of patient discharge.

by Visual Analogue Scale The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between "0 or no pain" and "100 or worst pain".

Al-Azhar University

Assistant lecturer

Clear Cell Renal Cell Carcinoma

Stage pT1 and pT2 according to pathology results of patients who underwent partial or radical nephrectomy.

Stage ≥pT3a according to pathology results of patients who underwent partial or radical nephrectomy.

The preoperative imaging of the participants, who were grouped according to the postoperative pathology results, will be examined.

No intervention will be applied.

Selman Unal

The investigators aimed to evaluate the role of some findings that can be detected in preoperative radiological imaging of kidney masses in predicting locally advanced disease.

Renal cell carcinoma (RCC) is one of the most common urinary system cancers and accounts for 3% of all cancers. With the frequent use of imaging methods most renal masses are detected localized. The standard treatment option in localized RCC is radical nephrectomy (RN) or nephron-sparing surgery (NSS). NSS is preferred when appropriate in patients with tumor stage 1 (T1) and has been shown to be comparable to RN in terms of oncologic outcomes. Although there is no prospective randomized study comparing NSS with RN in terms of oncological and renal functions in T2 patients, there are retrospective studies conducted to date. According to the current European urology guideline, the standard approach in patients with T2 and above is RN. Pre-operative clinical staging is performed with computed tomography (CT) or magnetic resonance imaging (MRI), and patients may develop local recurrence despite surgical procedures based on clinical stage. Pre-operative the patient and in the management of local disease. In clinical practice, pre-operative CT and MRI provide information about tumor size, tumor localization, presence of tumor invasion into vascular structures and adjacent organs. However, apart from these frequently reported findings, there are CT and MRI findings that can be used to predict advanced disease. In the 2017 Tumor, node, metastasis (TNM) classification, invasion of the pelvicalyceal system, perirenal or renal sinus fat invasion has been included in the T3a category. There are studies evaluating predictive value of CT to indicate renal sinus fat or perirenal fat invasion. Although not in the standard TNM classification, it has been shown that renal capsule invasion is an independent prognostic variable for advanced disease and can be detected on CT. On the other hand, it has been indicated that thickening of the Gerota's fascia, the presence of enlarged collateral vessels, and the presence of intra-tumoral necrosis may be imaging findings that can be used to predict advanced disease. The investigators think that the markers evaluated so far in pre-operative imaging and some additional markers may predict advanced disease in RCC. The investigators also think that the predictive value of MRI may be higher than CT. Therefore, in this study the investigators evaluated some predictive features (Renal capsule invasion, perirenal fat invasion, thickening of the Gerota's fascia, presence of enlarged collateral vessels, tumor necrosis, perinephric stranding) of pre-operative computed tomography and magnetic resonance imaging for advanced disease in renal cell carcinoma.

Predictive Imaging Features in Renal Cell Carcinoma

Predictive Features of Pre-operative Computed Tomography and Magnetic Resonance Imaging for Advanced Disease in Renal Cell Carcinoma

Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) renal capsule invasion.

Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) perirenal fat tissue invasion

Whether there was a difference between the two groups in terms of the presence of pre-operative imaging (CT and MRI) thickening of the Gerota's fascia.

Ankara Yildirim Beyazıt University

Principal Investigator

Cysts

partial nephrectomy performed with the da Vinci Surgical System

partial nephrectomy performed with conventional laparoscopic surgery

Partial nephrectomy is the standard technique for organ-sparing resection of renal tumors. The EAU Guidelines recommend partial nephrectomy to all patients with T1 tumours and can be performed either with an open, pure laparoscopic or robot-assisted approach, based on surgeon's expertise and skills.

partial nephrectomy

In this trial the investigators want to examine and compare oncological and surgical outcomes of two surgical techniques in a prospective, randomised, single-blind trial. Therefore the investigators are going to include 30 patients with a renal mass who need surgical treatment. When they fulfill the inclusion criteria they get randomised either for robot-assisted partial nephrectomy or laparoscopic partial nephrectomy. Primary endpoint is the oncological outcome (residual tumor classification, TNM classification), secondary endpoints are operation time, time of ischemia, blood loss, pain after surgery, kidney function, complications and hospital stay.

All patients taking part in the study are first given a R.E.N.A.L. nephrometry score. Based on that score they are allocate to either of :

cohort I (low complexity of the tumour) or cohort II (intermediate complexity of the tumour).

Thereafter, the patient will be randomly placed into either to laparoscopic partial nephrectomy or robotic-assisted partial nephrectomy. Both these surgical techniques are well established and standardized procedures to remove a renal mass.

Preoperatively, the preparation is nearly the same for both techniques. The patient is positioned in flank position with the affected side up.

Thereafter:

Pneumoperitoneum is achieved with a Veress needle and trocars which are placed under direct vision. The only difference between the two techniques is the number of trocars, performing the laparoscopic partial nephrectomy three or four ports are used, performing the robotic-assisted partial nephrectomy five ports are used.

Intraabdominal, the kidney is exposed by incising along the Toldt line to moblize the colon. After exposing the ureter and the gonadal vein dissection is continued proximally toward the renal hilum. Following this, Gerota's fascia is incised to expose the tumour and the surrounding renal capsule. Now the renal artery has to be clamped to avoid bleeding followed by excision of the tumour. The surgery takes about three hours, the complication rate is more the same for both techniques.

Primary endpoint is the resection margin to see if there are any difference between the two surgical techniques.

Information about the resection margin and pathological staging will be given through our pathological department. The histological examination normally takes about five to seven days.

Further parameters are taken by following schema:

Information about age, sex, body mass index, other diseases and medication is documented on the day of inpatient admission.

Blood samples for haemoglobin and kidney function are taken at the day of inpatient admission, four hours after surgery, first day after surgery and the day of discharge from hospital.

The duration of surgery is documented throughout the operative protocol. R.E.N.A.L Nephrometry score is evaluated preoperative, to be able to compare the complexity of surgery.

Renal ischemia is documented throughout the operative protocol. Blood loss is documented during surgery. Pain is documented with the aid of the visual analogue scale (VAS Scale). This will be evaluated four hours after surgery, day one after surgery, day two after surgery and on the day of discharge from hospital.

Complications are documented with the aid of the clavien-dindo classification. Three follow-ups will be performed. The first follow-up will be held two weeks after surgery to discuss the histological result and examine haemoglobin, kidney function and pain. The second follow-up will be held six months after surgery, the third follow-up 12 months after surgery. At this time a re-examination again haemoglobin and kidney function will be performed as well as a computed tomography.

a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy

Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy: A Prospective, Randomised, Single-blind Trial Comparing Two Surgical Techniques

The tumor status following further treatment is described by the residual tumor classification. R0 means no residual tumor, R1 means microscopic residual tumor. The investigators are going to examine if there are any significant differences concerning tumor status between these two surgical techniques

Time of warm ischemia during laparoscopic or robot-assisted partial nephrectomy

The amount of blood loss during performing partial nephrectomy

Postoperative pain is going to be documented with the aid of the visual analogue scale. The visual analogue scale is a validated, subjective measure for pain. With the aid of a scale from zero to ten which represents a continuum between 'no pain' (0) and 'worst pain' (10) the subjective pain of each participant will be evaluated. This will be done four hours after surgery, day one after surgery, day two after surgery and on the day of discharge from hospital.

Before and after surgery blood samples are taken to evaluate the kidney function with the aid of Serum creatinine and the glomerular Filtration rate

Postoperative complications evaluated by 'clavien-dindo' classification

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS)	NCT03821376	Renal Malignant...	Contrast enhanc...	18 Years -	Indiana University
Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy	NCT03528057	Robotic-Assiste... Hemostatic Agen... Renal Malignant...	Hemostat	18 Years - 89 Years	Northwestern University
Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy	NCT03528057	Robotic-Assiste... Hemostatic Agen... Renal Malignant...	Hemostat	18 Years - 89 Years	Northwestern University
Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors	NCT05728957	Kidney Tumor Renal Benign Ne... Renal Malignant...		18 Years -	Loyola University
Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors	NCT05728957	Kidney Tumor Renal Benign Ne... Renal Malignant...		18 Years -	Loyola University
Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy	NCT06322745	Renal Tumor Renal Malignant...	Suture renorrha... Thulium beam co...	16 Years -	Al-Azhar University
Predictive Imaging Features in Renal Cell Carcinoma	NCT05042089	Renal Malignant...	No intervention...	20 Years - 80 Years	Ankara Yildirim Beyazıt University
Predictive Imaging Features in Renal Cell Carcinoma	NCT05042089	Renal Malignant...	No intervention...	20 Years - 80 Years	Ankara Yildirim Beyazıt University
a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy	NCT03900364	Carcinoma, Rena... Renal Malignant... Renal Cyst Renal Tumor	partial nephrec...	18 Years -	Salzburger Landeskliniken

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