AzTrials
AzTrials

Renal CancerNCT04213157

Laparoscopic Partial Nephrectomy for cT1 Tumors

An observational study of Renal Cancer and Renal Neoplasm, run by Samsun Liv Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 82 years
Conditions the study is for
Renal Cancer, Renal Neoplasm, Renal Cell Carcinoma
How many people
292 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Mar 2019to 10 Nov 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 82 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Liv hospital samsun

    Samsun, 55020

  • Ondokuz Mayıs University

    Samsun, 55030

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
laparoscopic partial nephrectomy, Trifecta, Pentafecta, Outcomes
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell, Neoplasms, Urologic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operation time

    time from onset to complete of surgery

    Measured: at the end of the surgery

  2. Blood loss

    amount of bleeding during surgery (mL)

    Measured: at the end of the surgery

  3. warm ischemia time

    The clamp time of the renal artery and vein which is required to complete tumor excision and renorrhaphy

    Measured: at the and of the surgery

  4. intraoperative complication

    abnormal problmes that may be seen during surgery

    Measured: at the end of the surgery

  5. Postoperative complication

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

    Measured: up to 3 months

  6. functional outcomes

    serum creatinine level and estimated glomerular filtration rate

    Measured: up to 1 year postoperatively

  7. surigcal margin status

    presence or absence of tumors at the surgical margin

    Measured: up to 1 month postoperatively

  8. Relative decrease in renal function

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

    Measured: up to 1 year postoperatively

  9. CKD stage upgrading

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

    Measured: up to 1 year postoperatively

  10. Oncological outomes

    Presence or absence of local and/or distal tumor recurrence

    Measured: up to the last clinical control (months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2019
  2. Study start15 Mar 2019
  3. Primary completion30 Aug 2019
  4. Study completion10 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04213157
Sponsor's protocol ID
OMU KAEK 2019/241
Status last verified
Dec 2019
First submitted
25 Dec 2019
Last updated
2 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is not yet known if there will be a plan to make IPD available.

Publications

  • 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.

    PubMed 23937616

  • 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.

    PubMed 24013181

  • 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.

    PubMed 26251228

  • 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.

    PubMed 18632142

  • 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.

    PubMed 32967451

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Cancer and Renal Neoplasm, run by Samsun Liv Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operation time (time frame: at the end of the surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04213157, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.

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