Study to Compare Two Partial Nephrectomy Techniques for Renal Tumors: Robot-assisted vs Videolaparoscopic

NCT06441851 | Not Yet Recruiting

• 1 other identifier: NP5030/2023
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, open-label clinical trial to compare renal volumetry pre and post operative in patients undergoing two types of partial nephrectomy techniques for renal tumors: robot-assisted vs videolaparoscopic.

Conditions

Renal Cancer

Keywords

Renal cancer; Nephrectomy; Partial nephrectomy; Videolaparoscopic partial nephrectomy; Robot-assisted partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• Renal volumetry

  Renal volumetry measured by computadorized tomography

  Up to 6 months after surgery

Study Arms (2)

Videolaparoscopic Partial Nephrectomy (VPN)

ACTIVE COMPARATOR

Patients randomized to VPN group will be submitted to a videolaparoscopic partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures.

Procedure: Videolaparoscopic Partial Nephrectomy

Robot-assisted Partial Nephrectomy (RANP)

EXPERIMENTAL

Patients randomized to RAN'P group will be submitted to a robot-assisted partial nephrectomy in which lesion will be identified, renal artery will be selectively clamped and renal parenchyma will be section with scissors and cautery. Suture will be made in two planes with absorbable sutures.

Procedure: Robot-assisted Partial Nephrectomy

Interventions

Videolaparoscopic Partial Nephrectomy PROCEDURE

Videolaparoscopic partial nephrectomy

Also known as: VPN

Videolaparoscopic Partial Nephrectomy (VPN)

Robot-assisted Partial Nephrectomy PROCEDURE

Robot-assisted partial nephrectomy

Also known as: RAPN

Robot-assisted Partial Nephrectomy (RANP)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 99 years old;
• Patients with non-metastatic renal cancer (confirmed by pre operatory TC);
• Patients eligible for videolaparoscopic partial nephrectomy;
• Patients who signed study informed consent form

You may not qualify if:

• Pregnant patients;
• Patients with concomitant indications with nephrectomy;
• Patients with a clinical condition that contraindicates nephrectomy;
• Patients with a clinical condition that contraindicates robot-assisted surgeries (determined by urology team);
• Patients with previous surgeries that contraindicates robot-assisted surgeries (determined by urology team);

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Related Publications (9)

• Campbell S, Uzzo RG, Allaf ME, Bass EB, Cadeddu JA, Chang A, Clark PE, Davis BJ, Derweesh IH, Giambarresi L, Gervais DA, Hu SL, Lane BR, Leibovich BC, Pierorazio PM. Renal Mass and Localized Renal Cancer: AUA Guideline. J Urol. 2017 Sep;198(3):520-529. doi: 10.1016/j.juro.2017.04.100. Epub 2017 May 4.

  PMID: 28479239 BACKGROUND

• Kutikov A, Uzzo RG. The R.E.N.A.L. nephrometry score: a comprehensive standardized system for quantitating renal tumor size, location and depth. J Urol. 2009 Sep;182(3):844-53. doi: 10.1016/j.juro.2009.05.035. Epub 2009 Jul 17.

  PMID: 19616235 BACKGROUND

• Thompson RH, Lane BR, Lohse CM, Leibovich BC, Fergany A, Frank I, Gill IS, Blute ML, Campbell SC. Every minute counts when the renal hilum is clamped during partial nephrectomy. Eur Urol. 2010 Sep;58(3):340-5. doi: 10.1016/j.eururo.2010.05.047. Epub 2010 Jun 9.

  PMID: 20825756 BACKGROUND

• Kim SP, Thompson RH, Boorjian SA, Weight CJ, Han LC, Murad MH, Shippee ND, Erwin PJ, Costello BA, Chow GK, Leibovich BC. Comparative effectiveness for survival and renal function of partial and radical nephrectomy for localized renal tumors: a systematic review and meta-analysis. J Urol. 2012 Jul;188(1):51-7. doi: 10.1016/j.juro.2012.03.006. Epub 2012 May 14.

  PMID: 22591957 BACKGROUND

• Kutikov A, Egleston BL, Canter D, Smaldone MC, Wong YN, Uzzo RG. Competing risks of death in patients with localized renal cell carcinoma: a comorbidity based model. J Urol. 2012 Dec;188(6):2077-83. doi: 10.1016/j.juro.2012.07.100. Epub 2012 Oct 18.

  PMID: 23083850 BACKGROUND

• Venkatesan AM, Kundu S, Sacks D, Wallace MJ, Wojak JC, Rose SC, Clark TW, d'Othee BJ, Itkin M, Jones RS, Miller DL, Owens CA, Rajan DK, Stokes LS, Swan TL, Towbin RB, Cardella JF; Society of Interventional Radiology Standards of Practice Committee. Practice guidelines for adult antibiotic prophylaxis during vascular and interventional radiology procedures. Written by the Standards of Practice Committee for the Society of Interventional Radiology and Endorsed by the Cardiovascular Interventional Radiological Society of Europe and Canadian Interventional Radiology Association [corrected]. J Vasc Interv Radiol. 2010 Nov;21(11):1611-30; quiz 1631. doi: 10.1016/j.jvir.2010.07.018. No abstract available.

  PMID: 21029949 BACKGROUND

• Lane BR, Abouassaly R, Gao T, Weight CJ, Hernandez AV, Larson BT, Kaouk JH, Gill IS, Campbell SC. Active treatment of localized renal tumors may not impact overall survival in patients aged 75 years or older. Cancer. 2010 Jul 1;116(13):3119-26. doi: 10.1002/cncr.25184.

  PMID: 20564627 BACKGROUND

• Zini L, Perrotte P, Capitanio U, Jeldres C, Shariat SF, Antebi E, Saad F, Patard JJ, Montorsi F, Karakiewicz PI. Radical versus partial nephrectomy: effect on overall and noncancer mortality. Cancer. 2009 Apr 1;115(7):1465-71. doi: 10.1002/cncr.24035.

  PMID: 19195042 BACKGROUND

• Ficarra V, Novara G, Secco S, Macchi V, Porzionato A, De Caro R, Artibani W. Preoperative aspects and dimensions used for an anatomical (PADUA) classification of renal tumours in patients who are candidates for nephron-sparing surgery. Eur Urol. 2009 Nov;56(5):786-93. doi: 10.1016/j.eururo.2009.07.040. Epub 2009 Aug 4.

  PMID: 19665284 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: June 4, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share