Residual Normal Renal Parenchymal and Tumor Volume in Tumor Surgeries

Renal Cell Carcinoma Clinical Trial

Official title:

Operable Primary Renal Tumors: Pre and Post-operative Volume Evaluation of the Tumor and Rest of the Kidney

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04244136
• Other study ID #: renal tissue volume in tumors
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: mohammed ragab, MD
• Phone: 01066237580
• Email: mohammedurology14290[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. Calculation of the expected residual renal tissue volume using contrast CT in renal tumor patients and its effect on preoperative decision making

2. Calculating the modulation between the residual normal renal tissue volume measured 6 months post operatively and the preoperative estimated normal renal tissue volume.

3. Assessment of the value of adding residual normal renal tissue volume to the PADUA score in decision making.

4. To reach a suggested cut off value of residual renal tissue that is adequate for a NSS trial

Description:

The oncological outcome achieved by NSS is considered equivalent to RN in patients with stage T1 renal tumors and as the benefits of NSS become apparent, the indications and application of NSS continue to expand to involve even higher stages of renal tumors, These trails were successful to achieve nearly a similar oncological outcome, however the functional outcome of the residual renal volume was not calculated because most of these studies depend only on the radiographic stage of the tumor. And it is not logic to expose the patients to the risk of NSS surgery with dissection of a large tumor volume to leave only small residual renal tissue volume that may not have enough benefit. To balance this risk benefit ratio, preoperative assessment of expected residual renal tissue volume can be calculated using contrast CT for all patients with renal masses must be done to reach a cutoff point for the least residual volume of renal tissue that should be left postoperatively to achieve a significant function, and to decide whether to do NSS or to proceed to radical surgery from the start.

The technical skill of the surgeon and the anatomical features of the renal tumor are important factors. The contribution of each factor to treatment choice and outcome are particularly relevant because the physician treatment recommendations are subject to training patterns biases, comfort levels and individual experience also the kidney doesn't follow an anatomical partitioning since designation of independent renal segments based on vascular distributions or collecting duct branching is not possible. Nevertheless, renal anatomy does contain consistent and easily reproducible landmarks which can be used by radiologists and surgeons to describe and quantify pertinent features of renal masses therefore Preoperative Aspects and Dimensions Used for an Anatomical Classification (PADUA) scoring system have emerged for quantifying the anatomical features relevant to surgical decision-making and to predict the risk of surgical and medical perioperative complications in renal tumor patients.

1. Preoperative assessment:

1. Using contrast CT radiologist will measure the expected residual renal tissue volume ( total renal tissue volume) and PADUA score.

2. GFR Calculation by Cockcroft-Gault formula.

2. Operative technique:

NSS will be done whenever possible by open approach, according to PADUA score hot ischemia with clamping of the renal artery will be done in less complicated mass while cold ischemia with cooling of the kidney surface after clamping of both renal artery and vein will be done in more complicated masses, Enculation of the mass will be done whenever possible, excision will be done if needed then closure of renal defect will be done only if necessary.

Radical nephrectomy will be done only in more complicated cases that are not amenable for NSS by open or laparoscopic approach through early ligation of the renal artery and vein, removal of the kidney outside Gerota's fascia, with or without removal of the ipsilateral adrenal gland, and performance of a complete regional lymphadenectomy whenever possible.

3. Post-operative assessment:

1. In case of NSS ,immediately post operatively the volume of the mass excised will be measured using graded jar and after 6 months contrast CT for measuring the residual ipsilateral parenchymal renal volume and the volume of the other kidney will be done by the same radiologist who had previously assessed the case (blinded to the preoperative data).

2. In case of radical nephrectomy, immediately post operatively we will separate the mass from normal renal tissue in the specimen excised then the volume of the mass and the normal renal tissue will be measured using graded jar. After 6 months the volume of the other kidney will be measured by the same radiologist who had previously assessed the case (blinded to the preoperative data)

3. Residual GFR calculation by GFR Calculation by Cockcroft-Gault formula.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients presented to oncology outpatient clinic in Assuit urology hospital diagnosed by contrast CT to have renal mass who are surgically fit for radical nephrectomy or NSS surgery.

Exclusion Criteria:

• 1-Patient who diagnosed to have stage T4 renal mass according to TNM staging. 2-CRI patients who cannot perform contrast study. 3-patients with tumors in non-functioning kidney 4-patients with secondary renal tumors

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Device:
• contrast CT
contrast CT abdomen fir measurement of the volume of expected residual normal renal tissue before surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Isotani S, Shimoyama H, Yokota I, Noma Y, Kitamura K, China T, Saito K, Hisasue S, Ide H, Muto S, Yamaguchi R, Ukimura O, Gill IS, Horie S. Novel prediction model of renal function after nephrectomy from automated renal volumetry with preoperative multidetector computed tomography (MDCT). Clin Exp Nephrol. 2015 Oct;19(5):974-81. doi: 10.1007/s10157-015-1082-6. Epub 2015 Jan 25. — View Citation

Long CJ, Canter DJ, Kutikov A, Li T, Simhan J, Smaldone M, Teper E, Viterbo R, Boorjian SA, Chen DY, Greenberg RE, Uzzo RG. Partial nephrectomy for renal masses = 7 cm: technical, oncological and functional outcomes. BJU Int. 2012 May;109(10):1450-6. doi: 10.1111/j.1464-410X.2011.10608.x. Epub 2012 Jan 5. — View Citation

Venkatramani V, Swain S, Satyanarayana R, Parekh DJ. Current Status of Nephron-Sparing Surgery (NSS) in the Management of Renal Tumours. Indian J Surg Oncol. 2017 Jun;8(2):150-155. doi: 10.1007/s13193-016-0587-0. Epub 2017 Jan 30. Review. — View Citation

Zhang M, Zhao Z, Duan X, Deng T, Cai C, Wu W, Zeng G. Partial versus radical nephrectomy for T1b-2N0M0 renal tumors: A propensity score matching study based on the SEER database. PLoS One. 2018 Feb 28;13(2):e0193530. doi: 10.1371/journal.pone.0193530. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimation of the efficacy of contrast CT IN Calculation of the expected residual normal renal tissue volume before renal tumor surgeries	comparision between preopertive measured volume by CT and post operative measured volume by CT in NSS and by graded gar in radical nephrectomy after isolation of the normal renal tissue in extracted kidney	3 years
Secondary	Assessment of the value of adding residual normal renal tissue volume to the PADUA score in decision making To reach a suggested cut off value of residual renal tissue that is adequate for a NSS trial	study the efficacy of residual normal renal tissue volume in decision making in tumor surgeries and if it have a true rule it what is the cut of value for NSS and can it be added as a fixed measurement to the items of PADUA score	4 years