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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

The patients undergoing partial nephrectomy.

The patients undergoing renal tumor enucleation.

Yichun Zheng, Doctor

Partial nephrectomy(PN) and tumor enucleation(TE) are the two main methods of Nephron-sparing surgery for early renal cell carcinoma. Because of its blunt separation, TE is often considered to be difficult to completely remove tumor tissue. In addition, compared with PN, TE is more difficult and has higher professional requirements for surgeons. Therefore most surgeons use PN. But Many studies have shown that TE has advantages over PN such as less trauma, faster recovery, and better protection of renal function without increasing the risk of tumor recurrence.

The main renal artery should be clamped during PN to achieve a relatively bloodless operation environment to ensure the safety of tumor resection. However, too long warm ischemia time will inevitably affect the function of normal renal tissue. Studies have shown that shortening the time of renal ischemia is closely related to the recovery of renal function after the operation. So reducing the time of warm ischemia until zero ischemia has become the pursuit of surgeons. Based on renal cell carcinoma resection combined with zero ischemia technique, renal parenchyma, and renal function can be protected to the maximum extent on the premise of ensuring tumor safety.

The purpose of this study is to explore the safety and efficacy of zero-ischemia TE by analyzing the data of early renal cell carcinoma patients who had undergone PN and zero-ischemia TE before.

According to the inclusion and exclusion criteria，collecting the data of participants who have undergone partial nephrectomy or renal tumor enucleation.

The investigators will compare the difference between TE and PN, clamped-enucleation and unclamped-enucleation, suture and sutureless zero-ischemia enucleation by the data the investigators collected.

After analysing the data, the investigators will discuss the safety and efficay of the sutureless zero-ischemia tumor enucleation. The patient who would be benefited from this operation and the patient who would be suggested to undergo this operation will also be discussed.

Safety and Efficacy of Sutureless Zero Ischemia Laparoscopic Tumor Enucleation for T1 Stage Renal Carcinoma

Serum creatinine of patients before and after operation and follow-up

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Comparing contrast enhanced US with biopsy result

Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.

Definity

Patients with an incidentally discovered small renal masses (SRM) \< 4 cm in diameter are included. All patients will undergo biopsy for tissue diagnosis. Most patients will be followed by imaging. Study intervention includes low MI US to be performed following both bolus and infusion injection of Definity contrast. Presence and absence of vascularity, pattern of vascularity, and TIC values will be correlated with the final pathology to find features differentiating benign from malignant masses.

Efficacy of Ultrasound Contrast Agent to Assess Renal Masses

The Comparison of Accuracy of Contrast Enhanced Ultrasound on Diagnosis of Small Renal Masses and Distinguishing Renal Cell Carcinomas From Other Renal Masses, With Biopsy

Lantheus Medical Imaging

University Health Network, Toronto

Subjects receive a renal cell biopsy prior to making a decision about treatment

Subjects do not receive a renal cell biopsy prior to making a decision about treatment

Subjects will receive a small renal mass biopsy prior to making a treatment decision

Small Renal Mass Biopsy

Subjects will not receive a small renal mass biopsy prior to making a treatment decision

No Small Renal Mass Biopsy

Hung J Tan, MD

Purpose: The purpose of this study is to evaluate the role of renal mass biopsy on decision-making for patients presenting with clinical T1 kidney tumors. This study also incorporates integrated biomarker study to compare the genomic data obtained through biopsy tissue to genomic information from surgical data.

Primary Objective

1. To compare the decisional conflict between patients who undergo renal mass biopsy during their evaluation for SRMs versus those who do not.
2. To validate the concordance of RNA sequencing (RNAseq) and genomic-based risk stratification molecular biomarkers between renal biopsy tissue and surgical (nephrectomy) specimen tissue.

Secondary objective

1. To characterize the impact of biopsy on patient reported anxiety and uncertainty, assessment of cancer care communication, and satisfaction with cancer care.

GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses

Decisional conflict scale between patients who undergo renal mass biopsy, and who do not will be compared. Decisional conflict scale is a validated, 16-item instrument that measures personal perceptions of decision-making. It yields a total score from 0 to 100 (higher scores indicate more decisional conflict) and sub-scores for perceptions of uncertainty, informed values clarity, support, and effectiveness in decision-making.

The proportion of patients undergoing nephrectomy (radical and partial nephrectomy) between patients who undergo renal mass biopsy versus those who do not will be compared.

Molecular subtype (ccA vs ccB) and the presence of genomic mutations between the renal mass biopsy and the surgical nephrectomy specimen will be compared.

Patient-reported anxiety will be assessed using the Short Form PROMIS Anxiety scale. Short Form PROMIS Anxiety is a validated 4-item survey of generalized anxiety, consisting of 5 questions, each scored using a 5-point Likert scale. High scores reflect better results.

Patient-reported cancer worry will be assessed using the Brief Worry Scale which is a 4 questions assessment designed to measure the relationship between worry and an event or behavior. This study will use the brief worry scale to measure the relationship between worry and the diagnosis of a small renal mass.

Patient-reported Risk Perception will be assessed using 2 two-question instrument to assign a numeric risk score for patients regarding incidental renal lesions, which may facilitate accurate risk comprehension.

Patient-reported uncertainty will be assessed using the Short-Form Mishel Uncertainty of Illness Scale which is a validated instrument that measures the patient's perception of the uncertainty of symptoms, diagnosis, treatment, and prognosis as well as the uncertainty subscale of the Decisional Conflict Scale. The scores are summed to yield a total score with a higher score indicating greater uncertainty.

Patient-reported regret about the decision will be assessed using the Decisional regret scale. Decisional Regret scale is a 5-item regret scale that measures distress or remorse after a healthcare decision. The short form consists of 5 questions, each scored using a 5-point Likert scale, indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree).

Patient-reported health-related quality of life will be assessed using The PROMIS Global Health scale is an 8-item, validated survey that represents five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). Higher score indicating better quality of life.

The validated 6-item Short-Form for Patient-Centered Communication-Cancer Scale. This is a validated, 6-item instrument that measures the patient's perspective on communication in cancer care. It incorporates questions relating to exchanging information, fostering relationships, making decisions, responding to emotions, enabling self-efficacy, and managing uncertainty. Each item is scored 1-5, and the overall score is an average of 6 questions, with 5 indicating the most satisfaction. A high score indicates better communication.

The proportion of patients undergoing ablation, radiation therapy, nephrectomy between patients who undergo renal mass biopsy versus those who do not will be compared

UNC Lineberger Comprehensive Cancer Center

Coagulants

All Drugs and Chemicals

Hemostatics

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

Disease Progression

Michael AS Jewett, MD, FRCSC

There is a rising incidence of incidentally detected small renal tumours due to improved imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo surgery and therefore there is limited data about the natural history of these tumours. Several small series have reported that most of these small masses grow slowly and might not require early intervention and that only some masses grow rapidly requiring immediate surgery. Presently, the investigators have not been able to identify prospectively which masses are going to grow slowly. The investigators plan to use computed tomography (CT) and Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to determine which masses will behave more aggressively. Additionally, the observations on the natural history of small renal masses need to be validated with a multicentric and systematically followed cohort.

Hypothesis

Since most renal cell carcinomas (RCC's) that are now detected by imaging as small renal masses, grow slowly and remain asymptomatic for years, we hypothesize that:

* Small RCC's that are destined to metastasize do so early or after they reach a larger size
* Delayed surgical treatment of asymptomatic, incidentally detected, small RCC's WILL NOT have a significant impact on overall survival
* The majority of small RCC's MAY NOT need to be treated.
* RCC's that are destined to progress can be identified by abnormal perfusion patterns on imaging and by their cellular and genomic characteristics on needle biopsy.

Biopsy cores, nephrectomy tissue, and blood and urine will be collected

The Natural History of Small Renal Masses

Role of Active Surveillance and Identification of Prognostic Factors for Progression in Early Stage Renal Cell Carcinoma

i) calculated tumour volume doubles (100% increase) within any one-year period, and/or ii) the maximum tumour diameter reaches 4 cm., and/or iii) patients develop symptoms considered to be possibly due to their renal tumour and/or iv) patients develop metastases

Time to tumour progression will be measured from the date of diagnosis to the date of progression or, if progression has not occurred, until the date of last follow-up.

Defined by volume (cm3 ) measured over time (years). Tumour bi-dimensional diameter will be recorded and reported to allow comparison with the literature to date. Tumour volume will be calculated from follow-up images using the formula for ellipsoid volume: 0.5326 x X x Y x Z.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Sutureless Zero Ischemia Laparoscopic Tumor Enucleation for T1 Stage Renal Carcinoma	NCT05790122	Carcinoma, Rena... Kidney Neoplasm...		18 Years - 80 Years	The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Efficacy of Ultrasound Contrast Agent to Assess Renal Masses	NCT01062178	Renal Cell Carc...	Definity	-	University Health Network, Toronto
Safety and Efficacy of Sutureless Zero Ischemia Laparoscopic Tumor Enucleation for T1 Stage Renal Carcinoma	NCT05790122	Carcinoma, Rena... Kidney Neoplasm...		18 Years - 80 Years	The Fourth Affiliated Hospital of Zhejiang University School of Medicine
GRADE-SRM: Genomic Risk Assessment and Decisional Evaluation for Small Renal Masses	NCT03819569	Small Renal Mas... Kidney Tumor	Small Renal Mas... No Small Renal ...	18 Years - 95 Years	UNC Lineberger Comprehensive Cancer Center
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
The Natural History of Small Renal Masses	NCT01305330	Patients With N...		18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for small renal mass