NCT04213157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

December 25, 2019

Last Update Submit

December 27, 2019

Conditions

Renal CancerRenal NeoplasmRenal Cell CarcinomaSurgerySurgery--ComplicationsRenal Functional AbnormalityOncologyOncology ProblemKidney IschemiaKidney InjuryUrologic NeoplasmsUrologic CancerKidney Neoplasms

Keywords

laparoscopic partial nephrectomyTrifectaPentafectaOutcomes

Outcome Measures

Primary Outcomes (10)

  • Operation time

    time from onset to complete of surgery

    at the end of the surgery

  • Blood loss

    amount of bleeding during surgery (mL)

    at the end of the surgery

  • 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

  • intraoperative complication

    abnormal problmes that may be seen during surgery

    at the end of the surgery

  • Postoperative complication

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

    up to 3 months

  • functional outcomes

    serum creatinine level and estimated glomerular filtration rate

    up to 1 year postoperatively

  • surigcal margin status

    presence or absence of tumors at the surgical margin

    up to 1 month postoperatively

  • Relative decrease in renal function

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

    up to 1 year postoperatively

  • CKD stage upgrading

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

    up to 1 year postoperatively

  • Oncological outomes

    Presence or absence of local and/or distal tumor recurrence

    up to the last clinical control (months)

Eligibility Criteria

Age18 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Functioning contraleteral kidney
  • Patients with complete data
  • Patients with single renal tumor on the effected side
  • Patients who approved the written consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liv hospital samsun

Samsun, 55020, Turkey (Türkiye)

Location

Ondokuz Mayıs University

Samsun, 55030, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 23937616RESULT

  • 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.

    PMID: 24013181RESULT

  • 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.

    PMID: 26251228RESULT

  • 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.

    PMID: 18632142RESULT

  • Mercimek MN, Ozden E, Gulsen M, Yakupoglu YK, Bostanci Y, Sarikaya S. Which Is the Best Predictor to Achieve Trifecta in Patients Undergoing Elective Laparoscopic Partial Nephrectomy with Global Hilar Clamping? Comparative Analysis in Patients with Clinical T1a and T1b Renal Tumors. J Endourol. 2021 May;35(5):615-622. doi: 10.1089/end.2020.0758. Epub 2020 Nov 5.

    PMID: 32967451DERIVED

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal CellNeoplasmsUrologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Saban Sarıkaya, Professor

    Ondokuz Mayıs University

    STUDY CHAIR

  • Ender Ozden, Professor

    Ondokuz Mayıs University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2019

First Posted

December 30, 2019

Study Start

March 15, 2019

Primary Completion

August 30, 2019

Study Completion

November 10, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

TU(2)