Residual Normal Renal Parenchymal and Tumor Volume in Tumor Surgeries

October 7, 2020 updated by: mohammed ragab abdallah, Assiut University

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

  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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: diaaelden abdelhamed, PHD
  • Phone Number: 01001229936

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

renal tumor patients who are fit for renal tumor surgeries

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
estimation of the efficacy of contrast CT IN Calculation of the expected residual normal renal tissue volume before renal tumor surgeries
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 4 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • renal tissue volume in tumors

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Cell Carcinoma

Clinical Trials on contrast CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe