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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213157
Other study ID # OMU KAEK 2019/241
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2019
Est. completion date November 10, 2019

Study information

Verified date December 2019
Source Samsun Liv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 292
Est. completion date November 10, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 82 Years
Eligibility 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


Locations

Country Name City State
Turkey Liv hospital samsun Samsun
Turkey Ondokuz Mayis University Samsun

Sponsors (2)

Lead Sponsor Collaborator
Samsun Liv Hospital Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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; — View 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. — View 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 2 — View 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 — View Citation

Outcome

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