Skip to content

Laparoscopic Partial Nephrectomy for cT1 Tumors

Evaluation Trifecta and Pentafecta Outcomes of Patients Underwent Laparoscopic Partial Nephrectomy for cT1 Renal Tumor

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04213157
Enrollment
292
Registered
2019-12-30
Start date
2019-03-15
Completion date
2019-11-10
Last updated
2020-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Injury, Kidney Ischemia, Kidney Neoplasms, Oncology, Oncology Problem, Renal Cancer, Renal Cell Carcinoma, Renal Functional Abnormality, Renal Neoplasm, Surgery, Surgery--Complications, Urologic Cancer, Urologic Neoplasms

Keywords

laparoscopic partial nephrectomy, Trifecta, Pentafecta, Outcomes

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.

Interventions

None listed

Sponsors

Ondokuz Mayıs University
CollaboratorOTHER
Samsun Liv Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 82 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Operation timeat the end of the surgerytime from onset to complete of surgery
Blood lossat the end of the surgeryamount of bleeding during surgery (mL)
warm ischemia timeat the and of the surgeryThe clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy
intraoperative complicationat the end of the surgeryabnormal problmes that may be seen during surgery
Postoperative complicationup to 3 monthsabnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
functional outcomesup to 1 year postoperativelyserum creatinine level and estimated glomerular filtration rate
surigcal margin statusup to 1 month postoperativelypresence or absence of tumors at the surgical margin
Relative decrease in renal functionup to 1 year postoperativelyComparison of preoperative and postoperative renal functions according to numerical and percentile values
CKD stage upgradingup to 1 year postoperativelyevaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
Oncological outomesup to the last clinical control (months)Presence or absence of local and/or distal tumor recurrence

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026