Clinical trial NCT04213157: Laparoscopic Partial Nephrectomy for cT1 Tumors
Official title: Evaluation Trifecta and Pentafecta Outcomes of Patients Underwent Laparoscopic Partial Nephrectomy for cT1 Renal Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cancer
Renal Neoplasm
Renal Cell Carcinoma
Surgery
Surgery--Complications
Renal Functional Abnormality
Oncology
Oncology Problem
Kidney Ischemia
Kidney Injury
Urologic Neoplasms
Urologic Cancer
Kidney Neoplasms
Keywords: laparoscopic partial nephrectomy
Trifecta
Pentafecta
Outcomes
Lead sponsor: Samsun Liv Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2019-12-30
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred ninety-two patients who have a follow-up at least 12 months were included in the study. Those were allocated into two groups according to radiological tumor size; 215 patients with tumor size ≤ 40 mm were included in group T1a and 77 patients with tumor size 41-70 mm were included in group T1b.

Brief summary: The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.

Detailed description: From November 2009 to August 2018 a total of 292 patients who underwent LPN by global ischemia were included in the study. The patients were allocated into two groups according to the tumor size; T1a (≤ 40 mm, n=215), T1b (41-70 mm, n=77). Demographics features, clinical tumor characteristics, intraoperative and postoperative outcomes were analyzed. A negative surgical margin, warm ischemia time (WIT) \< 20 min and no postoperative complications (Clavien-Dindo ≥ grade 3) were accepted to achieve the trifecta outcomes. Pentafecta has defined as trifecta criteria plus \>90% preservation of estimated glomerular filtration rate (eGFR) and no stage upgrade of chronic kidney disease 12 months after LPN. Univariable and multivariable analysis were used to identify factors predicting trifecta and pentafecta achievement.

Eligibility criteria: Inclusion Criteria:

* Functioning contraleteral kidney
* Patients with complete data
* Patients with single renal tumor on the effected side
* Patients who approved the written consent form

Exclusion Criteria:

* The patients with bilateral renal tumors (n=8, 16 LPNs)
* solitary kidney (n=8)
* horseshoe kidney (n=4)
* pelvic ectopic kidney (n=2)
* graft kidney (n=2)
* those with multiple renal tumors in a single kidney (n=3) or with \> 7 cm renal tumor (n=6)
* Patients who were operated on for colon cancer (n=4), prostate cancer (n=2), endometrial cancer (n=1) or adrenal mass (n=2) within the first year after LPN

Primary outcomes:
measure: Operation time
timeFrame: at the end of the surgery
measure: Blood loss
timeFrame: at the end of the surgery
measure: warm ischemia time
timeFrame: at the and of the surgery
measure: intraoperative complication
timeFrame: at the end of the surgery
measure: Postoperative complication
timeFrame: up to 3 months
measure: functional outcomes
timeFrame: up to 1 year postoperatively
measure: surigcal margin status
timeFrame: up to 1 month postoperatively
measure: Relative decrease in renal function
timeFrame: up to 1 year postoperatively
measure: CKD stage upgrading
timeFrame: up to 1 year postoperatively
measure: Oncological outomes
timeFrame: up to the last clinical control (months)
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Liv hospital samsun
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Saban Sarıkaya, Professor
role: STUDY_CHAIR
affiliation: Ondokuz Mayıs University
name: Ender Ozden, Professor
role: STUDY_DIRECTOR
References:
citation: Porpiglia F, Bertolo R, Amparore D, Fiori C. Margins, ischaemia and complications rate after laparoscopic partial nephrectomy: impact of learning curve and tumour anatomical characteristics. BJU Int. 2013 Dec;112(8):1125-32. doi: 10.1111/bju.12317. Epub 2013 Aug 13.
citation: Minervini A, Siena G, Antonelli A, Bianchi G, Bocciardi AM, Cosciani Cunico S, Ficarra V, Fiori C, Fusco F, Mari A, Martorana G, Medica M, Mirone V, Morgia G, Porpiglia F, Rocco F, Rovereto B, Schiavina R, Simeone C, Terrone C, Volpe A, Carini M, Serni S; Members of the RECORd Project-LUNA Foundation. Open versus laparoscopic partial nephrectomy for clinical T1a renal masses: a matched-pair comparison of 280 patients with TRIFECTA outcomes (RECORd Project). World J Urol. 2014 Feb;32(1):257-63. doi: 10.1007/s00345-013-1155-7. Epub 2013 Sep 7.
citation: Osaka K, Makiyama K, Nakaigawa N, Yao M. Predictors of trifecta outcomes in laparoscopic partial nephrectomy for clinical T1a renal masses. Int J Urol. 2015 Nov;22(11):1000-5. doi: 10.1111/iju.12893. Epub 2015 Aug 6.
citation: Rais-Bahrami S, Romero FR, Lima GC, Kohanim S, Permpongkosol S, Trock BJ, Jarrett TW, Kavoussi LR. Elective laparoscopic partial nephrectomy in patients with tumors >4 cm. Urology. 2008 Sep;72(3):580-3. doi: 10.1016/j.urology.2008.05.027. Epub 2008 Jul 16.
citation: Mercimek MN, Ozden E, Gulsen M, Yakupoglu YK, Bostanci Y, Sarikaya S. Which Is the Best Predictor to Achieve Trifecta in Patients Undergoing Elective Laparoscopic Partial Nephrectomy with Global Hilar Clamping? Comparative Analysis in Patients with Clinical T1a and T1b Renal Tumors. J Endourol. 2021 May;35(5):615-622. doi: 10.1089/end.2020.0758. Epub 2020 Nov 5.