Laparoscopic Partial Nephrectomy for cT1 Tumors

Completed

• Conditions: Surgery; Oncology; Oncology Problem; Surgery--Complications; Kidney Ischemia; Renal Neoplasm; Renal Functional Abnormality; Kidney Injury; Urologic Cancer; Renal Cancer

• Registration Number: NCT04213157
• Lead Sponsor: Samsun Liv Hospital

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.

Study Timeline

• Study Start: 2019-03-15
• Primary Completion: 2019-08-30
• Study Completion: 2019-11-10
• Status Verified: 2019-12
• Study First Submitted: 2019-12-25
• Study First Submitted QC: 2019-12-25
• Last Update Submitted: 2019-12-27
• Study First Posted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Operation time	at the end of the surgery	time from onset to complete of surgery
Blood loss	at the end of the surgery	amount of bleeding during surgery (mL)
CKD stage upgrading	up to 1 year postoperatively	evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
Oncological outomes	up to the last clinical control (months)	Presence or absence of local and/or distal tumor recurrence
warm ischemia time	at the and of the surgery	The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy
intraoperative complication	at the end of the surgery	abnormal problmes that may be seen during surgery
Postoperative complication	up to 3 months	abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
functional outcomes	up to 1 year postoperatively	serum creatinine level and estimated glomerular filtration rate
surigcal margin status	up to 1 month postoperatively	presence or absence of tumors at the surgical margin
Relative decrease in renal function	up to 1 year postoperatively	Comparison of preoperative and postoperative renal functions according to numerical and percentile values

Trial Locations

Locations (2)

Ondokuz Mayıs University; 🇹🇷 Samsun, Turkey

Liv hospital samsun; 🇹🇷 Samsun, Turkey