Nephron Sparing Renal Surgery and Total Nephrectomy

NCT02646293 | Completed

• 1 other identifier: SN-43-2012
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of the diagnosis of renal cell carcinoma has increased during the past two decades because of the detection of small renal tumours that occur incidentally because of increased use of CT-scanning (1,2). Postoperative renal insufficiency was a significant independent predictor of overall and cardiovascular specific survival (3). "Nephron-sparing" surgical techniques are now preferred for small tumor masses and laparoscopic intervention is replacing open surgery at centers that master this technique. This is an area of priority within the Regions of Zaeland and Southern Denmark. The primary endpoint is: The early plasma (5 days) \[NT-proBNP\] response predicts long-term total renal function and function of the remaining kidney. The second endpoint: Plasma \[NT-proBNP\] increases acutely after partial nephrectomy and the change reflects the renal mass reduction. Chronic blood pressure change is inversely related to plasma \[BNP\].

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• NT-proBNP

  5 days

Secondary Outcomes (2)

• Partial nephrectomy_proBNP

  5 days

• Chronic blood pressure

  12 months

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study is designed as an observational, longitudinal study where plasma \[NT-proBNP\], renal function and blood pressure is followed in patients undergoing partial or total nephrectomy ("nephron sparing surgery") and relate this to plasma BNP.

You may qualify if:

• Patients suspected to have renal tumors by CT/Ultrasonic-scanning and eligible for intervention.
• Healthy kidney donors scheduled for donation
• Patients aged between 25 and 80 years
• Patients can read and understand Danish

You may not qualify if:

• Severe hypertension or congestive heart failure in New York Heart Association (NyHA) classes III-IV.
• Renal insufficiency with glomerular filtration rate (eGFR) \<50%
• Failure to comply

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

Location

Related Publications (7)

• Janzen NK, Kim HL, Figlin RA, Belldegrun AS. Surveillance after radical or partial nephrectomy for localized renal cell carcinoma and management of recurrent disease. Urol Clin North Am. 2003 Nov;30(4):843-52. doi: 10.1016/s0094-0143(03)00056-9.

  PMID: 14680319 RESULT

• Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

  PMID: 18287387 RESULT

• Patel N, Sullivan M, Cranston D. Re: 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: C. J. Weight, B. T. Larson, A. F. Fergany, T. Gao, B. R. Lane, S. C. Campbell, J. H. Kaouk, E. A. Klein and A. C. Novick J Urol 2010; 183: 1317-1323. J Urol. 2010 Nov;184(5):2213-4; author reply 2214. doi: 10.1016/j.juro.2010.06.127. Epub 2010 Sep 22. No abstract available.

  PMID: 20864134 RESULT

• Becker F, Van Poppel H, Hakenberg OW, Stief C, Gill I, Guazzoni G, Montorsi F, Russo P, Stockle M. Assessing the impact of ischaemia time during partial nephrectomy. Eur Urol. 2009 Oct;56(4):625-34. doi: 10.1016/j.eururo.2009.07.016. Epub 2009 Jul 28.

  PMID: 19656615 RESULT

• Gill IS, Kavoussi LR, Lane BR, Blute ML, Babineau D, Colombo JR Jr, Frank I, Permpongkosol S, Weight CJ, Kaouk JH, Kattan MW, Novick AC. Comparison of 1,800 laparoscopic and open partial nephrectomies for single renal tumors. J Urol. 2007 Jul;178(1):41-6. doi: 10.1016/j.juro.2007.03.038. Epub 2007 May 11.

  PMID: 17574056 RESULT

• Azawi NH, Christensen T. Promising early results after hand-assisted laparoscopic partial nephrectomy in carefully selected patients. Dan Med J. 2012 Oct;59(10):A4520.

  PMID: 23158896 RESULT

• Luchner A, Hengstenberg C, Lowel H, Riegger GA, Schunkert H, Holmer S. Effect of compensated renal dysfunction on approved heart failure markers: direct comparison of brain natriuretic peptide (BNP) and N-terminal pro-BNP. Hypertension. 2005 Jul;46(1):118-23. doi: 10.1161/01.HYP.0000170140.36633.8f. Epub 2005 Jun 6.

  PMID: 15939804 RESULT

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nessn Azawi, M.D.

  Roskilde University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 5, 2016
• Study Start: May 1, 2016
• Primary Completion: February 13, 2022
• Study Completion: December 31, 2022
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)