Laparoscopic Partial Nephrectomy for cT1 Tumors

NCT ID: NCT04213157

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-15

Study Completion Date

2019-11-10

Brief Summary

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

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role collaborator

Samsun Liv Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Necmettin Mercimek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saban Sarıkaya, Professor

Role: STUDY_CHAIR

Ondokuz Mayıs University

Ender Ozden, Professor

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

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Liv hospital samsun

Samsun, , Turkey (Türkiye)

Site Status

Ondokuz Mayıs University

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 23937616 (View on PubMed)

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.

Reference Type RESULT
PMID: 24013181 (View on PubMed)

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.

Reference Type RESULT
PMID: 26251228 (View on PubMed)

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.

Reference Type RESULT
PMID: 18632142 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32967451 (View on PubMed)

Other Identifiers

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OMU KAEK 2019/241

Identifier Type: -

Identifier Source: org_study_id

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