A Study of 3D Visualization Techniques to Improve the Quality and Safety of Robot-assisted Nephron Sparing Surgery for Complex Renal Tumors.

NCT06717009 | Not Yet Recruiting FDA Device

• 1 other identifier: E20241351
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From start of arterial clamping to release of arterial blocking forceps during surgery, an average of 25 minutes.

Secondary Outcomes (9)

• operative time

  From the beginning to the end of the surgery, an average of 3 hours.

• Intraoperative bleeding

  From the beginning to the end of the surgery, an average of 3 hours.

• Length of postoperative hospital stay

  an average of a week.

• Incidence of postoperative complications

  an average of a week.

• Positive rate of pathological margin

  an average of a week.

Study Arms (2)

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.

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.

Interventions

Preoperative three-dimensional reconstruction DIAGNOSTIC_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.

3D trial group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Sir Run Run Shaw Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Peking University First Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Qilu Hospital of Shandong University: collaborator
• Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• West China Hospital: collaborator
• Tongji Hospital: collaborator
• Sun Yat-sen University Tumor Hospital: collaborator
• Shanghai Cancer Hospital, China: collaborator
• Shengjing Hospital: collaborator

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Location

Related Publications (8)

• 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.

  PMID: 22305422 BACKGROUND

• Piramide 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.

  PMID: 36216739 BACKGROUND

• Amparore 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.

  PMID: 33903083 BACKGROUND

• Porpiglia 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.

  PMID: 29317081 BACKGROUND

• Gu 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.

  PMID: 32561096 BACKGROUND

• Sagalovich 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.

  PMID: 29984597 BACKGROUND

• Cacciamani 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.

  PMID: 29580709 BACKGROUND

• Weight 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.

  PMID: 20171688 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Xin Yao

CONTACT

86 18622221103; liaowf2011@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 4, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

CN (1)