Laparoscopic Partial Nephrectomy for cT1 Tumors

December 27, 2019 updated by: Mehmet Necmettin Mercimek, Samsun Liv Hospital

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

The aim of the study is to evaluate trifecta and pentafecta outcomes for laparoscopic partial nephrectomy (LNP) in patients with clinical T1N0M0 renal tumor.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55030
        • Ondokuz Mayıs University
      • Samsun, Turkey, 55020
        • Liv Hospital Samsun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 82 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: at the end of the surgery
time from onset to complete of surgery
at the end of the surgery
Blood loss
Time Frame: at the end of the surgery
amount of bleeding during surgery (mL)
at the end of the surgery
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
at the and of the surgery
intraoperative complication
Time Frame: at the end of the surgery
abnormal problmes that may be seen during surgery
at the end of the 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
up to 3 months
functional outcomes
Time Frame: up to 1 year postoperatively
serum creatinine level and estimated glomerular filtration rate
up to 1 year postoperatively
surigcal margin status
Time Frame: up to 1 month postoperatively
presence or absence of tumors at the surgical margin
up to 1 month postoperatively
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
up to 1 year postoperatively
CKD stage upgrading
Time Frame: up to 1 year postoperatively
evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
up to 1 year postoperatively
Oncological outomes
Time Frame: up to the last clinical control (months)
Presence or absence of local and/or distal tumor recurrence
up to the last clinical control (months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun Liv Hospital

Collaborators

Ondokuz Mayıs University

Investigators

  • Study Chair: Saban Sarıkaya, Professor, Ondokuz Mayıs University
  • Study Director: Ender Ozden, Professor, Ondokuz Mayıs University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

November 10, 2019

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 27, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMU KAEK 2019/241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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