Renal CancerNCT04933604
LPN in Patients With High-complex Renal Tumors
An observational study of Renal Cancer and Renal Neoplasm, run by Samsun Liv Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cancer, Renal Neoplasm, Renal Cell Carcinoma
- What is being tested?
- laparoscopic partial nephrectomy and Laparoscopic radical nephrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 4 Feb 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD) and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.
Who may be able to join
- Patients with complete data
- Patients with single renal tumor on the effected side
- Patients who approved the written consent form
Who cannot join
- Patients who not approved the written consent form
- Patients with incomplete data
- Patients with low or mild complexity renal tumors
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Department of Urology
Samsun, 55020
About this study
Official title: Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis
The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.
Read the detailed description
From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.
- Conditions
- Renal Cancer, Renal Neoplasm, Renal Cell Carcinoma, Surgery, Oncology, Kidney Ischemia
- Being tested
- laparoscopic partial nephrectomy, Laparoscopic radical nephrectomy
- Keywords
- Laparoscopy, nephrometry score, partial nephrectomy, propensity score matching, radical nephrectomy
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell, Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic partial nephrectomyProcedure or surgery
Nephron sparing minimally invasive surgery
Laparoscopic radical nephrectomyProcedure or surgery
Completely removal of kidney by using laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| LPN group | 39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy Receives: Procedure: laparoscopic partial nephrectomy | |
| LRN group | 39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy Receives: Procedure: Laparoscopic radical nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
time from onset to complete of surgery
Measured: at the end of the surgery
Blood loss
amount of bleeding during surgery (mL)
Measured: 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
Measured: at the and of the surgery
Postoperative complication
abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
Measured: up to 3 months postoperatively
functional outcomes
serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
Measured: 1 year after the surgery
surigcal margin status
presence or absence of tumors at the surgical margin
Measured: postoperative follow-up, through study completion, an average of 1 year
CKD stage upgrading
evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
Measured: postoperative follow-up, through study completion, an average of 1 year
Oncological outomes
Presence or absence of local and/or distal tumor recurrence
Measured: postoperative follow-up, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Sep 2019
- Primary completion30 May 2020
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun Liv Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Principal investigator, Mehmet Necmettin Mercimek, Samsun Liv Hospital
- Investigators
- Ender Ozden, Prof., Study director, Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalıSaban Sarıkaya, Prof., Study chair, Ondokuz Mayıs University, Faculty of Medicine, Department of UrologyMehmet Mercimek, MD, FEBU, Principal investigator, Liv Hospital Samsun, Department of UrologyYakup Bostancı, Prof., Principal investigator, Ondokuz Mayıs University, Faculty of Medicine, Department of UrologyMurat Gulsen, MD, Principal investigator, Samsun Gazi State Hospital, Departmen of Urology, Samsun, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933604
- Sponsor's protocol ID
- OMU KAEK 11.07.2019/538
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.
PubMed 27988238Mir MC, Derweesh I, Porpiglia F, Zargar H, Mottrie A, Autorino R. Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies. Eur Urol. 2017 Apr;71(4):606-617. doi: 10.1016/j.eururo.2016.08.060. Epub 2016 Sep 7.
PubMed 27614693Yang F, Zhou Q, Xing N. Comparison of survival and renal function between partial and radical laparoscopic nephrectomy for T1b renal cell carcinoma. J Cancer Res Clin Oncol. 2020 Jan;146(1):261-272. doi: 10.1007/s00432-019-03058-z. Epub 2019 Nov 1.
PubMed 31677114
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Partial Nephrectomy Versus Laparoscopic Radical Nephrectomy in Patients With High-Complexity Renal Tumors: A Propensity Score Matched Analysis
- ClinicalTrials.gov ID
- NCT04933604
- Acronym / sponsor ID
- OMU KAEK 11.07.2019/538
- Conditions
- Renal Cancer, Renal Neoplasm, Renal Cell Carcinoma, Surgery, Oncology, Kidney Ischemia
- Keywords
- Laparoscopy, nephrometry score, partial nephrectomy, propensity score matching, radical nephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Samsun Liv HospitalUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate the rationale for LPN in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.
Detailed description
From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD), and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPN group | – | Procedure: laparoscopic partial nephrectomy39 patients with high complexity renal tumors who underwent laparoscopic partial nephrectomy |
| LRN group | – | Procedure: Laparoscopic radical nephrectomy39 patients with high complexity renal tumors who underwent laparoscopic radical nephrectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From November 2009 to October 2018, 399 patients underwent LPN and 307 patients to laparoscopic radical nephrectomy (LRN). 41 patients with RENAL score ≥ 10 enrolled in LPN and 265 patients to the LRN group. Propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (DM), hypertension (HT), coronary artery disease (CAD) and final tumor pathology of RCC) was used to reduce selection bias. Functional and oncological outcomes were compared between the two groups. After propensity score analysis, 39 patients in the LRN group were matched with 39 in the LPN group.
Key inclusion criteria (3 listed)
- Patients with complete data
- Patients with single renal tumor on the effected side
- Patients who approved the written consent form
Key exclusion criteria (3 listed)
- Patients who not approved the written consent form
- Patients with incomplete data
- Patients with low or mild complexity renal tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic partial nephrectomyNephron sparing minimally invasive surgery | Procedure or surgery | LPN group |
| Laparoscopic radical nephrectomyCompletely removal of kidney by using laparoscopic surgery | Procedure or surgery | LRN group |
Primary outcome
Operation time
Time frame: at the end of the surgery
time from onset to complete of surgery
Blood loss
Time frame: at the end of the surgery
amount of bleeding during surgery (mL)
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
Postoperative complication
Time frame: up to 3 months postoperatively
abnormal problmes that may be seen after surgery and require additional intervention, treatment or follow-up
functional outcomes
Time frame: 1 year after the surgery
serum creatinine level (mg /dL) and estimated glomerular filtration rate (CKD Epidemiology Collaboration (CKD-EPI) equation) (mL/min/1.73 m2)
surigcal margin status
Time frame: postoperative follow-up, through study completion, an average of 1 year
presence or absence of tumors at the surgical margin
CKD stage upgrading
Time frame: postoperative follow-up, through study completion, an average of 1 year
evaluation of preoperative and postoperative renal functions according to chronic kidney disease stages
Oncological outomes
Time frame: postoperative follow-up, through study completion, an average of 1 year
Presence or absence of local and/or distal tumor recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Results publication: PubMed 27988238Kim SP, Campbell SC, Gill I, Lane BR, Van Poppel H, Smaldone MC, Volpe A, Kutikov A. Collaborative Review of Risk Benefit Trade-offs Between Partial and Radical Nephrectomy in the Management of Anatomically Complex Renal Masses. Eur Urol. 2017 Jul;72(1):64-75. doi: 10.1016/j.eururo.2016.11.038. Epub 2016 Dec 14.
- Results publication: PubMed 27614693Mir MC, Derweesh I, Porpiglia F, Zargar H, Mottrie A, Autorino R. Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies. Eur Urol. 2017 Apr;71(4):606-617. doi: 10.1016/j.eururo.2016.08.060. Epub 2016 Sep 7.
- Results publication: PubMed 31677114Yang F, Zhou Q, Xing N. Comparison of survival and renal function between partial and radical laparoscopic nephrectomy for T1b renal cell carcinoma. J Cancer Res Clin Oncol. 2020 Jan;146(1):261-272. doi: 10.1007/s00432-019-03058-z. Epub 2019 Nov 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ender Ozden, Prof. study director
Ondokuz Mayıs Üniversitesi, Tıp Fakültesi, Üroloji Anabilim dalı
Saban Sarıkaya, Prof. study chair
Ondokuz Mayıs University, Faculty of Medicine, Department of Urology
Mehmet Mercimek, MD, FEBU principal investigator
Liv Hospital Samsun, Department of Urology
1 site in 1 country: see every site and its status.
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 1 site 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 3 inclusion and 3 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 8 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 NCT04933604, which also lists 3 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 22 Jun 2021.