Δευτέρα 30 Δεκεμβρίου 2019

Laparoscopic Partial Nephrectomy for cT1 Tumors

Laparoscopic Partial Nephrectomy for cT1 Tumors: 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 Intervention:   Sponsors:   Samsun Liv Hospital;   Ondokuz Mayıs University Completed (Source: ClinicalTrials.gov)

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Laparoscopic Partial Nephrectomy for cT1 Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.



ClinicalTrials.gov Identifier: NCT04213157

Recruitment Status  : Completed

First Posted  : December 30, 2019

Last Update Posted  : December 30, 2019

Sponsor:

Samsun Liv Hospital

Collaborator:

Ondokuz Mayıs University

Information provided by (Responsible Party):

Mehmet Necmettin Mercimek, Samsun Liv Hospital



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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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.



Condition or disease

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



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 Design

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Study Type  : Observational

Actual Enrollment  : 292 participants

Observational Model: Cohort

Time Perspective: Retrospective

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

Actual Study Start Date  : March 15, 2019

Actual Primary Completion Date  : August 30, 2019

Actual Study Completion Date  : November 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma

U.S. FDA Resources



Groups and Cohorts

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Outcome Measures

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Primary Outcome Measures  :

Operation time [ Time Frame: at the end of the surgery ]

time from onset to complete of surgery



Blood loss [ Time Frame: at the end of the surgery ]

amount of bleeding during surgery (mL)



warm ischemia time [ Time Frame: 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 [ Time Frame: at the end of the surgery ]

abnormal problmes that may be seen during surgery



Postoperative complication [ Time Frame: up to 3 months ]

abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up



functional outcomes [ Time Frame: up to 1 year postoperatively ]

serum creatinine level and estimated glomerular filtration rate



surigcal margin status [ Time Frame: up to 1 month postoperatively ]

presence or absence of tumors at the surgical margin



Relative decrease in renal function [ Time Frame: up to 1 year postoperatively ]

Comparison of preoperative and postoperative renal functions according to numerical and percentile values



CKD stage upgrading [ Time Frame: up to 1 year postoperatively ]

evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages



Oncological outomes [ Time Frame: up to the last clinical control (months) ]

Presence or absence of local and/or distal tumor recurrence





Eligibility Criteria

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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.





Ages Eligible for Study:  18 Years to 82 Years   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

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.

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

Contacts and Locations

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.



Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213157





Locations

Turkey

Liv hospital samsun

Samsun, Turkey, 55020

Ondokuz Mayıs University

Samsun, Turkey, 55030

Sponsors and Collaborators

Samsun Liv Hospital

Ondokuz Mayıs University

Investigators

Study Chair: Saban Sarıkaya, Professor Ondokuz Mayıs University

Study Director: Ender Ozden, Professor Ondokuz Mayıs University

More Information

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Publications of Results:

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.

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.

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.

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.



Responsible Party: Mehmet Necmettin Mercimek, MD, Samsun Liv Hospital

ClinicalTrials.gov Identifier: NCT04213157     History of Changes

Other Study ID Numbers: OMU KAEK 2019/241

First Posted: December 30, 2019    Key Record Dates

Last Update Posted: December 30, 2019

Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD: Undecided

Plan Description: It is not yet known if there will be a plan to make IPD available.

Studies a U.S. FDA-regulated Drug Product: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mehmet Necmettin Mercimek, Samsun Liv Hospital:

laparoscopic partial nephrectomy

Trifecta

Pentafecta

Outcomes

Additional relevant MeSH terms:

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Ischemia

Neoplasms

Pathologic Processes

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Neoplasms by Site

Kidney Diseases

Urologic Diseases





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