Skip to main content
OpenTrials
Completed

NCT Number: NCT04213157

Laparoscopic Partial Nephrectomy for cT1 Tumors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Injury Kidney Ischemia Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oncology Oncology Problem Renal Cell Carcinoma Renal Functional Abnormality Renal Neoplasm Surgery Surgery--Complications Urogenital Diseases Urogenital Neoplasms Urologic Cancer Urologic Diseases Urologic Neoplasms

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liv hospital samsun, Samsun, Turkey (Türkiye)

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Operation time

    Time frame: at the end of the surgery

    time from onset to complete of surgery

  2. Blood loss

    Time frame: at the end of the surgery

    amount of bleeding during surgery (mL)

  3. 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

  4. intraoperative complication

    Time frame: at the end of the surgery

    abnormal problmes that may be seen during surgery

  5. Postoperative complication

    Time frame: up to 3 months

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

  6. functional outcomes

    Time frame: up to 1 year postoperatively

    serum creatinine level and estimated glomerular filtration rate

  7. surigcal margin status

    Time frame: up to 1 month postoperatively

    presence or absence of tumors at the surgical margin

  8. 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

  9. CKD stage upgrading

    Time frame: up to 1 year postoperatively

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

  10. Oncological outomes

    Time frame: up to the last clinical control (months)

    Presence or absence of local and/or distal tumor recurrence

Sponsors and collaborators

Lead sponsor

Samsun Liv Hospital

Other

Collaborators

  • Ondokuz Mayıs University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 30, 2019
Registry last updated
Jan 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.