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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
Go to sections
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
Go to sections
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
Go to sections
Outcome Measures
Go to sections
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
Go to sections
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
Go to sections
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
Go to sections
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
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
Hide glossaryGlossary
Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms
x
Accepts healthy volunteers
Active comparator arm
Adverse event
Age or age group
All-cause mortality
Allocation
Arm
Arm type
Baseline characteristics
Canceled submission
Certain agreements
Certification
Certification/extension first posted
Certification/extension first submitted
Certification/extension first submitted that met QC criteria
City and distance
Clinical study
Clinical trial
ClinicalTrials.gov identifier (NCT number)
Collaborator
Condition/disease
Contact
Country
Cross-over assignment
Data Monitoring Committee (DMC)
Early Phase 1 (formerly listed as Phase 0)
Eligibility criteria
Enrollment
Exclusion criteria
Expanded access
Expanded access status
Expanded access type
Experimental arm
Extension request
Factorial assignment
First posted
First submitted
First submitted that met QC criteria
Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801)
Funder type
Gender-based eligibility
Group/cohort
Human subjects protection review board
Inclusion criteria
Informed consent
Informed consent form (ICF)
Intervention model
Intervention/treatment
Interventional study (clinical trial)
Investigator
Last update posted
Last update submitted
Last update submitted that met QC criteria
Last verified
Listed location countries
Location terms
Masking
NCT number
No intervention arm
Observational study
Observational study model
Other adverse event
Other study IDs
Other terms
Outcome measure
Parallel assignment
Participant flow
Patient registry
Phase
Phase 1
Phase 2
Phase 3
Phase 4
Phase Not Applicable
Placebo
Placebo comparator arm
Primary completion date
Primary outcome measure
Primary purpose
Principal investigator (PI)
Protocol
Quality control (QC) review
Randomized allocation
Recruitment status
Registration
Removed location countries
Reporting group
Responsible party
Results database
Results delayed
Results first posted
Results first submitted
Results first submitted that met QC criteria
Results returned after quality control review
Results submitted to ClinicalTrials.gov
Secondary outcome measure
Serious adverse event
Sex
Sham comparator arm
Single group assignment
Sort studies by
Sponsor
State
Statistical analysis plan (SAP)
Status
Study completion date
Study design
Study documents
Study IDs
Study record
Study registry
Study results
Study start date
Study type
Submitted date
Title
Title acronym
U.S. Agency for Healthcare Research and Quality (AHRQ)
U.S. Food and Drug Administration (FDA)
Unknown
Skip to Main Content
ClinicalTrials.gov
Find StudiesFind Studies Menu
About StudiesAbout Studies Menu
Submit StudiesSubmit Studies Menu
ResourcesResources Menu
About SiteAbout Site Menu
HomeSearch ResultsStudy Record Detail Save this study
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
Go to sections
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
Go to sections
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
Go to sections
Outcome Measures
Go to sections
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
Go to sections
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
Go to sections
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
Go to sections
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
TO TOP
For Patients and Families For Researchers For Study Record Managers
HOME RSS FEEDS SITE MAP TERMS AND CONDITIONS DISCLAIMER CUSTOMER SUPPORT
Copyright Privacy Accessibility Viewers and Players Freedom of Information Act USA.gov
U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human Services
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