Kidney Neoplasms / SurgeryNCT06717009
A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors.
A study testing Preoperative three-dimensional reconstruction in people with Kidney Neoplasms / Surgery and Robotic Surgical Procedures, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the evidence-based medical value of 3D visualization techniques to improve tumor control, preservation of renal function, and perioperative safety in robot-assisted nephron sparing surgery for complex renal tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Neoplasms / Surgery, Robotic Surgical Procedures, Imaging, Three-Dimensional / Methods
- What is being tested?
- Preoperative three-dimensional reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Jan 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The imaging diagnosis is single renal cell carcinoma, clinical stage is T1N0M0-T2N0M0, and the contralateral kidney function is good.
- Physical status and organ function allow robotic-assisted partial nephrectomy.
- Be able to adhere to the protocol during the study.
- The age ranges from 18 to 75 years, and there is no chronic kidney disease.
- KPS > 80; ECOG score: 0-1; There are no other serious concomitant diseases and the organ function is good.
- There are no medical contraindications seriously affecting anesthesia and surgery.
Show all 9Show fewer
- The patient has no history of other malignant tumors in the past 5 years.
- There is no surgical history of epigastrium and the affected kidney.
- Estimated survival is more than 6 months, and there are no other severe diseases that reduce survival to less than 5 years.
Who cannot join
- Women who are pregnant or lactating, or who are of reproductive age and are not using effective contraception.
- Comorbid serious medical diseases or conditions, for example, clinically severe or active heart disease, severe uncontrolled medical illnesses and infections, severe uncontrolled digestive disorder, severe electrolyte disturbance, active disseminated intravascular coagulation, major organ failure such as decompensated cardiac, pulmonary, hepatic, or renal failure, symptomatic peripheral neuropathy. Can not tolerate robot-assisted laparoscopic partial nephrectomy
- Organ transplant recipients requiring immunosuppressive therapy.
- There is history of other malignancies within 5 years of trial initiation, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Patients who have received biological therapy or other anticancer traditional Chinese medicine within 4 weeks.
- Patients with multiple or bilateral renal tumors or solitary renal tumors.
- Patient without complete clinical information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Xin Yao, 86 18622221103, liaowf2011@163.com
Xin Yao
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study of Three-dimensional Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors
The goal of this clinical trial is to learn the evidence-based medical value of 3D visualization techniques to improve tumor control, preservation of renal function, and perioperative safety in robot-assisted nephron sparing surgery for complex renal tumors. The main question it aims to answer is:
Is 3D visualization techniques more effective in improving robot-assisted nephron sparing surgery for complex renal tumors in terms of tumor control, renal function preservation, and perioperative safety.
Read more
The researchers will randomize participants into a 3D trial group and a conventional group for comparison.
Participants will:
Complete Blood routine, liver and kidney function tests on the first and third day after operation.
Have Renography at 3 and 12 months after the operation. Cooperate with follow-up visits.
Read the detailed description
- Sample size: When designing this experiment, considering the warm ischemic time reported by our center and in the literature, with a test power of 80% (β= 0.2), a power value of 0.8, a one-sided type I error of 2.5% (α= 0.05), the sample size is calculated to be 242 cases. The enrollment is planned to last 2 years, and the follow-up results from enrollment to the initial stage are for 5 years. Calculated based on a 30% dropout rate, 350 cases are planned to be enrolled.
- Enrollment screening: Appropriate, reproducible methods should be used to evaluate the tumor prior to randomization (e.g., CT and/or MRI). The following evaluations should be made prior to randomization: demographic data, medical history (including concomitant disease and treatments), physical examination, pregnancy test (if necessary), special examinations (chest X-ray and ECG). The following evaluations should be made prior to randomization: vital signs and physical examination (including Karnofsky performance status score, height, and weight), hematological and biochemical examinations.
- Randomization: Patients who meet the selection criteria will be randomly allocated to the 3D trial group and the conventional group in a 1:1 ratio.
- Assessment During the Study Period: During the study period, patients' concomitant disease and treatments will be continuously monitored, and vital signs, weight, Karnofsky performance status score, hematological examinations (including white blood cells/neutrophils), and serum biochemical examinations will be conducted according to specified time intervals for each patient. An conventional ECG and chest X-ray/CT examination will be conducted prior to surgery. Tumor assessment will be conducted during the perioperative period (clinical examination, chest X-ray or chest CT/MRI, and abdominal CT/MRI). Laboratory examination indicators during the perioperative period should be recorded, such as preoperative and postoperative hematological and biochemical examinations. The focus is to complete the renogram to evaluate renal function within 1 month prior to surgery, and re-evaluating renal function with a renogram 3 months and 12 months after surgery to assess changes in renal function. No matter what surgical method is used, detailed records should be made of what was seen during the operation, the surgical method, operative data, and postoperative pathology. All patients should be followed up according to the study protocol, and PFS and OS should be recorded.
- Statistical Analysis:
Statistical analysis will be conducted using the SPSS 24.0 software package. Statistical descriptions will use rates for enumeration data, and means and 95% confidence intervals for measurement data. The t-test will be used to compare the measurement data between the two groups, the Chi-square test will be used to analyze the enumeration data, the Kaplan-Meier method will be used to calculate the survival curve, and the Log-rank test will be used to compare the two treatments.HR and 95% Confidence intervals for survival in subgroups will be determined with the multiple individual Cox models, which will separately measure the interaction between factors and treatment effect. The probability P value will be used for statistical inference regardless of the stage, and the statistically significant difference thresholds will be adopted as 0.05.
- Conditions
- Kidney Neoplasms / Surgery, Robotic Surgical Procedures, Imaging, Three-Dimensional / Methods, Nephrectomy / Methods
- Being tested
- Preoperative three-dimensional reconstruction
- Keywords
- Three-dimensional visualization technique;, Three-dimensional reconstruction, Robotic surgery, Kidney neoplasms, Laparoscopy, Nephron sparing surgery
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative three-dimensional reconstructionDiagnostic test
On the basis of conventional CT/MRI, the patient will undergo 3D reconstruction within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the 3D reconstruction and perform robot-assisted laparoscopic nephron sparing surgery.
| Study group | Role | What they receive |
|---|---|---|
| 3D trial group | Experimental | The three-dimensional reconstruction data of patients will be synthesized according to renal enhanced CT/MRI within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the three-dimensional reconstruction and perform robot-assisted laparoscopic nephron sparing surgery. Receives: Diagnostic Test: Preoperative three-dimensional reconstruction |
| Conventional group | No intervention | The patients will not undergo preoperative 3D reconstruction. The surgeon will arrange robot-assisted laparoscopic nephron sparing surgery according to routine CT/MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
warm ischemia time
The time from start of arterial clamping to release of arterial blocking forceps during surgery. Superselective arterial blockade will be recorded separately as a specific blockade modality. The arterial blocking time will be recorded as 0 for those without arterial blockage.
Measured: From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.
Secondary outcomes (9)
operative time
Measured: From the beginning to the end of the surgery, an average of 3 hours.
Intraoperative bleeding
Measured: From the beginning to the end of the surgery, an average of 3 hours.
Length of postoperative hospital stay
Measured: an average of a week.
Incidence of postoperative complications
Measured: an average of a week.
Positive rate of pathological margin
Measured: an average of a week.
Conversion rate
Laparoscopic surgery converts to open surgery, or partial nephrectomy converts to radical nephrectomy during the surgery.
Measured: From the beginning to the end of the surgery, an average of 3 hours.
Postoperative creatinine changes
Measured: 1 month
Changes in glomerular filtration rate
Measured: 3 month.
3-year recurrence-free survival rate
Measured: Within three years from the end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Kidney Neoplasms / SurgeryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The researchers will randomize participants into a 3D trial group and a conventional group for comparison. The 3D trials group will undergo preoperative 3D reconstruction, while the conventional group will only undergo routine CT/MRI.
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, Liaoning Cancer Hospital & Institute, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Chongqing Medical University, Qilu Hospital of Shandong University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Hebei Medical University Fourth Hospital, West China Hospital, Tongji Hospital, Sun Yat-sen University Tumor Hospital, Shanghai Cancer Hospital, China, Shengjing Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717009
- Sponsor's protocol ID
- E20241351
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Chen XS, Zhang ZT, Du J, Bi XC, Sun G, Yao X. Optimal surgical margin in nephron-sparing surgery for T1b renal cell carcinoma. Urology. 2012 Apr;79(4):836-9. doi: 10.1016/j.urology.2011.11.023. Epub 2012 Feb 2.
PubMed 22305422Piramide F, Kowalewski KF, Cacciamani G, Rivero Belenchon I, Taratkin M, Carbonara U, Marchioni M, De Groote R, Knipper S, Pecoraro A, Turri F, Dell'Oglio P, Puliatti S, Amparore D, Volpi G, Campi R, Larcher A, Mottrie A, Breda A, Minervini A, Ghazi A, Dasgupta P, Gozen A, Autorino R, Fiori C, Di Dio M, Gomez Rivas J, Porpiglia F, Checcucci E; European Association of Urology Young Academic Urologists and the European Section of Uro-Technology. Three-dimensional Model-assisted Minimally Invasive Partial Nephrectomy: A Systematic Review with Meta-analysis of Comparative Studies. Eur Urol Oncol. 2022 Dec;5(6):640-650. doi: 10.1016/j.euo.2022.09.003. Epub 2022 Oct 7.
PubMed 36216739Amparore D, Pecoraro A, Checcucci E, Piramide F, Verri P, De Cillis S, Granato S, Angusti T, Solitro F, Veltri A, Fiori C, Porpiglia F. Three-dimensional Virtual Models' Assistance During Minimally Invasive Partial Nephrectomy Minimizes the Impairment of Kidney Function. Eur Urol Oncol. 2022 Feb;5(1):104-108. doi: 10.1016/j.euo.2021.04.001. Epub 2021 Apr 24.
PubMed 33903083Porpiglia F, Fiori C, Checcucci E, Amparore D, Bertolo R. Hyperaccuracy Three-dimensional Reconstruction Is Able to Maximize the Efficacy of Selective Clamping During Robot-assisted Partial Nephrectomy for Complex Renal Masses. Eur Urol. 2018 Nov;74(5):651-660. doi: 10.1016/j.eururo.2017.12.027. Epub 2018 Jan 6.
PubMed 29317081Gu L, Liu K, Du S, Li H, Ma X, Huang Q, Ai Q, Chen W, Gao Y, Fan Y, Xie Y, Yao Y, Wang H, Li P, Xuan Y, Wang B, Zhang X. Prediction of pentafecta achievement following laparoscopic partial nephrectomy: Implications for robot-assisted surgery candidates. Surg Oncol. 2020 Jun;33:32-37. doi: 10.1016/j.suronc.2020.01.004. Epub 2020 Jan 7.
PubMed 32561096Sagalovich D, Dagenais J, Bertolo R, Garisto JD, Kaouk JH. Trifecta Outcomes in Renal Hilar Tumors: A Comparison Between Robotic and Open Partial Nephrectomy. J Endourol. 2018 Sep 12;32(9):831-836. doi: 10.1089/end.2018.0445.
PubMed 29984597Cacciamani GE, Medina LG, Gill T, Abreu A, Sotelo R, Artibani W, Gill IS. Impact of Surgical Factors on Robotic Partial Nephrectomy Outcomes: Comprehensive Systematic Review and Meta-Analysis. J Urol. 2018 Aug;200(2):258-274. doi: 10.1016/j.juro.2017.12.086. Epub 2018 Mar 24.
PubMed 29580709Weight CJ, Larson BT, Fergany AF, Gao T, Lane BR, Campbell SC, Kaouk JH, Klein EA, Novick AC. Nephrectomy induced chronic renal insufficiency is associated with increased risk of cardiovascular death and death from any cause in patients with localized cT1b renal masses. J Urol. 2010 Apr;183(4):1317-23. doi: 10.1016/j.juro.2009.12.030. Epub 2010 Feb 19.
PubMed 20171688
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study of Three-dimensional Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors
- ClinicalTrials.gov ID
- NCT06717009
- Acronym / sponsor ID
- E20241351
- Conditions
- Kidney Neoplasms / Surgery, Robotic Surgical Procedures, Imaging, Three-Dimensional / Methods, Nephrectomy / Methods
- Keywords
- Three-dimensional visualization technique;, Three-dimensional reconstruction, Robotic surgery, Kidney neoplasms, Laparoscopy, Nephron sparing surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, Liaoning Cancer Hospital & Institute, The Second Affiliated Hospital of Dalian Medical University, First Affiliated Hospital of Chongqing Medical University, Qilu Hospital of Shandong University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Hebei Medical University Fourth Hospital, West China Hospital, Tongji Hospital, Sun Yat-sen University Tumor Hospital, Shanghai Cancer Hospital, China, Shengjing Hospital
- Study start
- Jan 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Dec 2024 (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.
The goal of this clinical trial is to learn the evidence-based medical value of 3D visualization techniques to improve tumor control, preservation of renal function, and perioperative safety in robot-assisted nephron sparing surgery for complex renal tumors. The main question it aims to answer is:
Is 3D visualization techniques more effective in improving robot-assisted nephron sparing surgery for complex renal tumors in terms of tumor control, renal function preservation, and perioperative safety.
The researchers will randomize participants into a 3D trial group and a conventional group for comparison.
Participants will:
Complete Blood routine, liver and kidney function tests on the first and third day after operation.
Have Renography at 3 and 12 months after the operation. Cooperate with follow-up visits.
Detailed description
- Sample size: When designing this experiment, considering the warm ischemic time reported by our center and in the literature, with a test power of 80% (β= 0.2), a power value of 0.8, a one-sided type I error of 2.5% (α= 0.05), the sample size is calculated to be 242 cases. The enrollment is planned to last 2 years, and the follow-up results from enrollment to the initial stage are for 5 years. Calculated based on a 30% dropout rate, 350 cases are planned to be enrolled.
- Enrollment screening: Appropriate, reproducible methods should be used to evaluate the tumor prior to randomization (e.g., CT and/or MRI). The following evaluations should be made prior to randomization: demographic data, medical history (including concomitant disease and treatments), physical examination, pregnancy test (if necessary), special examinations (chest X-ray and ECG). The following evaluations should be made prior to randomization: vital signs and physical examination (including Karnofsky performance status score, height, and weight), hematological and biochemical examinations.
- Randomization: Patients who meet the selection criteria will be randomly allocated to the 3D trial group and the conventional group in a 1:1 ratio.
- Assessment During the Study Period: During the study period, patients' concomitant disease and treatments will be continuously monitored, and vital signs, weight, Karnofsky performance status score, hematological examinations (including white blood cells/neutrophils), and serum biochemical examinations will be conducted according to specified time intervals for each patient. An conventional ECG and chest X-ray/CT examination will be conducted prior to surgery. Tumor assessment will be conducted during the perioperative period (clinical examination, chest X-ray or chest CT/MRI, and abdominal CT/MRI). Laboratory examination indicators during the perioperative period should be recorded, such as preoperative and postoperative hematological and biochemical examinations. The focus is to complete the renogram to evaluate renal function within 1 month prior to surgery, and re-evaluating renal function with a renogram 3 months and 12 months after surgery to assess changes in renal function. No matter what surgical method is used, detailed records should be made of what was seen during the operation, the surgical method, operative data, and postoperative pathology. All patients should be followed up according to the study protocol, and PFS and OS should be recorded.
- Statistical Analysis:
Statistical analysis will be conducted using the SPSS 24.0 software package. Statistical descriptions will use rates for enumeration data, and means and 95% confidence intervals for measurement data. The t-test will be used to compare the measurement data between the two groups, the Chi-square test will be used to analyze the enumeration data, the Kaplan-Meier method will be used to calculate the survival curve, and the Log-rank test will be used to compare the two treatments.HR and 95% Confidence intervals for survival in subgroups will be determined with the multiple individual Cox models, which will separately measure the interaction between factors and treatment effect. The probability P value will be used for statistical inference regardless of the stage, and the statistically significant difference thresholds will be adopted as 0.05.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The researchers will randomize participants into a 3D trial group and a conventional group for comparison. The 3D trials group will undergo preoperative 3D reconstruction, while the conventional group will only undergo routine CT/MRI.
| Arm | Type | Receives |
|---|---|---|
| 3D trial group | Experimental | Diagnostic Test: Preoperative three-dimensional reconstructionThe three-dimensional reconstruction data of patients will be synthesized according to renal enhanced CT/MRI within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the three-dimensional reconstruction and perform robot-assisted laparoscopic nephron sparing surgery. |
| Conventional group | No intervention | –The patients will not undergo preoperative 3D reconstruction. The surgeon will arrange robot-assisted laparoscopic nephron sparing surgery according to routine CT/MRI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The imaging diagnosis is single renal cell carcinoma, clinical stage is T1N0M0-T2N0M0, and the contralateral kidney function is good.
- Physical status and organ function allow robotic-assisted partial nephrectomy.
- Be able to adhere to the protocol during the study.
- The age ranges from 18 to 75 years, and there is no chronic kidney disease.
- KPS > 80; ECOG score: 0-1; There are no other serious concomitant diseases and the organ function is good.
Key exclusion criteria (7 listed)
- Women who are pregnant or lactating, or who are of reproductive age and are not using effective contraception.
- Comorbid serious medical diseases or conditions, for example, clinically severe or active heart disease, severe uncontrolled medical illnesses and infections, severe uncontrolled digestive disorder, severe electrolyte disturbance, active disseminated intravascular coagulation, major organ failure such as decompensated cardiac, pulmonary, hepatic, or renal failure, symptomatic peripheral neuropathy. Can not tolerate robot-assisted laparoscopic partial nephrectomy
- Organ transplant recipients requiring immunosuppressive therapy.
- There is history of other malignancies within 5 years of trial initiation, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Patients who have received biological therapy or other anticancer traditional Chinese medicine within 4 weeks.
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 |
|---|---|---|
| Preoperative three-dimensional reconstructionOn the basis of conventional CT/MRI, the patient will undergo 3D reconstruction within 48 hours before surgery. The surgeon/researcher will conduct surgical planning according to the results of the 3D reconstruction and perform robot-assisted laparoscopic nephron sparing surgery. | Diagnostic test | 3D trial group |
Primary outcome
warm ischemia time
Time frame: From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.
The time from start of arterial clamping to release of arterial blocking forceps during surgery. Superselective arterial blockade will be recorded separately as a specific blockade modality. The arterial blocking time will be recorded as 0 for those without arterial blockage.
9 secondary outcomes
operative time
Time frame: From the beginning to the end of the surgery, an average of 3 hours.
Intraoperative bleeding
Time frame: From the beginning to the end of the surgery, an average of 3 hours.
Length of postoperative hospital stay
Time frame: an average of a week.
Incidence of postoperative complications
Time frame: an average of a week.
Positive rate of pathological margin
Time frame: an average of a week.
Conversion rate
Time frame: From the beginning to the end of the surgery, an average of 3 hours.
Postoperative creatinine changes
Time frame: 1 month
Changes in glomerular filtration rate
Time frame: 3 month.
3-year recurrence-free survival rate
Time frame: Within three years from the end of the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 22305422Chen XS, Zhang ZT, Du J, Bi XC, Sun G, Yao X. Optimal surgical margin in nephron-sparing surgery for T1b renal cell carcinoma. Urology. 2012 Apr;79(4):836-9. doi: 10.1016/j.urology.2011.11.023. Epub 2012 Feb 2.
- Background: PubMed 36216739Piramide F, Kowalewski KF, Cacciamani G, Rivero Belenchon I, Taratkin M, Carbonara U, Marchioni M, De Groote R, Knipper S, Pecoraro A, Turri F, Dell'Oglio P, Puliatti S, Amparore D, Volpi G, Campi R, Larcher A, Mottrie A, Breda A, Minervini A, Ghazi A, Dasgupta P, Gozen A, Autorino R, Fiori C, Di Dio M, Gomez Rivas J, Porpiglia F, Checcucci E; European Association of Urology Young Academic Urologists and the European Section of Uro-Technology. Three-dimensional Model-assisted Minimally Invasive Partial Nephrectomy: A Systematic Review with Meta-analysis of Comparative Studies. Eur Urol Oncol. 2022 Dec;5(6):640-650. doi: 10.1016/j.euo.2022.09.003. Epub 2022 Oct 7.
- Background: PubMed 33903083Amparore D, Pecoraro A, Checcucci E, Piramide F, Verri P, De Cillis S, Granato S, Angusti T, Solitro F, Veltri A, Fiori C, Porpiglia F. Three-dimensional Virtual Models' Assistance During Minimally Invasive Partial Nephrectomy Minimizes the Impairment of Kidney Function. Eur Urol Oncol. 2022 Feb;5(1):104-108. doi: 10.1016/j.euo.2021.04.001. Epub 2021 Apr 24.
- Background: PubMed 29317081Porpiglia F, Fiori C, Checcucci E, Amparore D, Bertolo R. Hyperaccuracy Three-dimensional Reconstruction Is Able to Maximize the Efficacy of Selective Clamping During Robot-assisted Partial Nephrectomy for Complex Renal Masses. Eur Urol. 2018 Nov;74(5):651-660. doi: 10.1016/j.eururo.2017.12.027. Epub 2018 Jan 6.
- Background: PubMed 32561096Gu L, Liu K, Du S, Li H, Ma X, Huang Q, Ai Q, Chen W, Gao Y, Fan Y, Xie Y, Yao Y, Wang H, Li P, Xuan Y, Wang B, Zhang X. Prediction of pentafecta achievement following laparoscopic partial nephrectomy: Implications for robot-assisted surgery candidates. Surg Oncol. 2020 Jun;33:32-37. doi: 10.1016/j.suronc.2020.01.004. Epub 2020 Jan 7.
- Background: PubMed 29984597Sagalovich D, Dagenais J, Bertolo R, Garisto JD, Kaouk JH. Trifecta Outcomes in Renal Hilar Tumors: A Comparison Between Robotic and Open Partial Nephrectomy. J Endourol. 2018 Sep 12;32(9):831-836. doi: 10.1089/end.2018.0445.
- Background: PubMed 29580709Cacciamani GE, Medina LG, Gill T, Abreu A, Sotelo R, Artibani W, Gill IS. Impact of Surgical Factors on Robotic Partial Nephrectomy Outcomes: Comprehensive Systematic Review and Meta-Analysis. J Urol. 2018 Aug;200(2):258-274. doi: 10.1016/j.juro.2017.12.086. Epub 2018 Mar 24.
- Background: PubMed 20171688Weight CJ, Larson BT, Fergany AF, Gao T, Lane BR, Campbell SC, Kaouk JH, Klein EA, Novick AC. Nephrectomy induced chronic renal insufficiency is associated with increased risk of cardiovascular death and death from any cause in patients with localized cT1b renal masses. J Urol. 2010 Apr;183(4):1317-23. doi: 10.1016/j.juro.2009.12.030. Epub 2010 Feb 19.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative three-dimensional reconstruction in people with Kidney Neoplasms / Surgery and Robotic Surgical Procedures, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 9 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Yao (86 18622221103, liaowf2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
warm ischemia time (time frame: From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.). 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 NCT06717009, which also lists 8 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 4 Dec 2024.