Laparoscopic Partial Nephrectomy for cT1 Tumors

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213157
• Other study ID #: OMU KAEK 2019/241
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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)