Renal Cell CarcinomaNCT04244136
Residual Normal Renal Parenchymal and Tumor Volume in Tumor Surgeries
An observational study of Renal Cell Carcinoma, run by Assiut University.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- contrast CT
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: renal tumor patients who are fit for renal tumor surgeries
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
diaaelden abdelhamed, PHD contact
About this study
Official title: Operable Primary Renal Tumors: Pre and Post-operative Volume Evaluation of the Tumor and Rest of the Kidney
- Calculation of the expected residual renal tissue volume using contrast CT in renal tumor patients and its effect on preoperative decision making
- Calculating the modulation between the residual normal renal tissue volume measured 6 months post operatively and the preoperative estimated normal renal tissue volume.
- 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
Read the 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.
- Preoperative assessment:
- Using contrast CT radiologist will measure the expected residual renal tissue volume ( total renal tissue volume) and PADUA score.
- GFR Calculation by Cockcroft-Gault formula.
- 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.
- Post-operative assessment:
- 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).
- 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)
- Residual GFR calculation by GFR Calculation by Cockcroft-Gault formula.
- Conditions
- Renal Cell Carcinoma
- Being tested
- contrast CT
- Keywords
- residual normal renal tissue
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast CTDevice
contrast CT abdomen fir measurement of the volume of expected residual normal renal tissue before surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (1)
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed ragab abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244136
- Sponsor's protocol ID
- renal tissue volume in tumors
- Status last verified
- Oct 2020
- First submitted
- 24 Jan 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22221502Isotani 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.
PubMed 25618493Zhang 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.
PubMed 29489911Venkatramani 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.
PubMed 28546710
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operable Primary Renal Tumors: Pre and Post-operative Volume Evaluation of the Tumor and Rest of the Kidney
- ClinicalTrials.gov ID
- NCT04244136
- Acronym / sponsor ID
- renal tissue volume in tumors
- Conditions
- Renal Cell Carcinoma
- Keywords
- residual normal renal tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Calculation of the expected residual renal tissue volume using contrast CT in renal tumor patients and its effect on preoperative decision making
- Calculating the modulation between the residual normal renal tissue volume measured 6 months post operatively and the preoperative estimated normal renal tissue volume.
- 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
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.
- Preoperative assessment:
- Using contrast CT radiologist will measure the expected residual renal tissue volume ( total renal tissue volume) and PADUA score.
- GFR Calculation by Cockcroft-Gault formula.
- 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.
- Post-operative assessment:
- 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).
- 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)
- Residual GFR calculation by GFR Calculation by Cockcroft-Gault formula.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- renal tumor patients who are fit for renal tumor surgeries
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast CTcontrast CT abdomen fir measurement of the volume of expected residual normal renal tissue before surgery | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 22221502Long 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.
- Background: PubMed 25618493Isotani 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.
- Background: PubMed 29489911Zhang 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.
- Background: PubMed 28546710Venkatramani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
diaaelden abdelhamed, PHD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed ragab, MD (01066237580, mohammedurology14290@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04244136, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.