Renal Cell CarcinomaNCT06424080
Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.
A study testing laparoscopic partial nephrectomy and robotic partial nephrectomy in people with Renal Cell Carcinoma, run by Menoufia University at 1 site in Egypt.
Trial summary
partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors. As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- laparoscopic partial nephrectomy and robotic partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal mass T1 according to TNM amenable for partial nephrectomy.
Who cannot join
- any unfit pt for partial nephrectomy
- more than 7cm tumor
- mass not amenable for partial nephrectomy
- metastatic tumor or locally advanced
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hossam Kandeel
Shibīn al Kawm, Menoufia -, 12345
hossam elsayed kandeel, MSC, 01097991198 ext. 002, hossamkandeel016@gmail.com
About this study
partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.
As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .
Read more
The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.
Moreover, robotic assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) seems to be significantly better than OPN in terms of perioperative complications, estimated blood loss and hospital stay. Conversely, transfusion rate, ischemia time, change in estimated glomerular filtration rate and early cancer outcomes are similar between the two approaches. International guidelines recommend the use of both approaches according to the surgeon and patient preferences.
so, we are plaining to do the study comparing between RAPN and LPN regarding feasibility and ability of both techniques.
Read the detailed description
Renal cell carcinoma (RCC) represents a significant burden of malignancy. Over the past 2-3 decades, the incidence of kidney cancer has steadily increased all around the world ,.The EUA Guidelines suggested that surgery is the only curative treatment for localized renal cell carcinoma.
Surgical treatment of RCC either radical or partial nephrectomy is related to the clinical stage of the disease and to the general condition of the patient. Modern medical imaging has further revolutionized the role of PN due to the increasing volume of incidentally diagnosed small renal masses.
Indeed, partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.
As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .
The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.
Moreover, robotic assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) seems to be significantly better than OPN in terms of perioperative complications, estimated blood loss and hospital stay. Conversely, transfusion rate, ischemia time, change in estimated glomerular filtration rate and early cancer outcomes are similar between the two approaches. International guidelines recommend the use of both approaches according to the surgeon and patient preferences.
so, we are plaining to do the study comparing between RAPN and LPN regarding feasibility and ability of both techniques.
- Conditions
- Renal Cell Carcinoma
- Being tested
- laparoscopic partial nephrectomy, robotic partial nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic partial nephrectomyProcedure or surgery
cases amenable for partial nephrectomy
robotic partial nephrectomyProcedure or surgery
cases amenable for partial nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic partial nephrectomy | Other | cases of renal cell carcinoma , localized tumors , candidate for laparoscopic partial nephrectomy Receives: Procedure: laparoscopic partial nephrectomy |
| robotic partial nephrectomy | Other | cases of renal cell carcinoma , localized tumors , candidate for robotic partial nephrectomy Receives: Procedure: robotic partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare between laparoscopic and robotic partial nephrectomy regards ischemia time
to compare between laparoscopic and robotic partial nephrectomy regards ischemia time
Measured: 1 year
Secondary outcomes (1)
compare between laparoscopic and robotic partial nephrectomy pathological safty margin
compare between laparoscopic and robotic partial nephrectomy pathological safty margin
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 May 2024
- Primary completion10 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Kandeel, Menoufia University
- Investigators
- hossam elsayed kandeel, MSC, Study director, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424080
- Sponsor's protocol ID
- 6-2024UROL12
- Status last verified
- Jun 2024
- First submitted
- 13 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.
- ClinicalTrials.gov ID
- NCT06424080
- Acronym / sponsor ID
- 6-2024UROL12
- Conditions
- Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 May 2024 (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.
partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.
As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .
The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.
Moreover, robotic assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) seems to be significantly better than OPN in terms of perioperative complications, estimated blood loss and hospital stay. Conversely, transfusion rate, ischemia time, change in estimated glomerular filtration rate and early cancer outcomes are similar between the two approaches. International guidelines recommend the use of both approaches according to the surgeon and patient preferences.
so, we are plaining to do the study comparing between RAPN and LPN regarding feasibility and ability of both techniques.
Detailed description
Renal cell carcinoma (RCC) represents a significant burden of malignancy. Over the past 2-3 decades, the incidence of kidney cancer has steadily increased all around the world ,.The EUA Guidelines suggested that surgery is the only curative treatment for localized renal cell carcinoma.
Surgical treatment of RCC either radical or partial nephrectomy is related to the clinical stage of the disease and to the general condition of the patient. Modern medical imaging has further revolutionized the role of PN due to the increasing volume of incidentally diagnosed small renal masses.
Indeed, partial nephrectomy offers lower renal function impairment and equivalent oncological survival outcomes compared with radical nephrectomy in those with T1 tumors.
As urology has embraced the gradual shift from open to minimally invasive surgery (MIS), PN is being completed more often by laparoscopic and robotic methods .
The first laparoscopic transperitoneal partial nephrectomy was reported in 1993 by Winfield, with the retroperitoneal approach introduced 1 year later With advancing robotic technology and the development of the DaVinci system, urologists began to explore the realm of robotic-assisted urologic surgery. In 2004, Gettman et al. published a paper describing their experience with robotic-assisted laparoscopic partial nephrectomy.
Moreover, robotic assisted partial nephrectomy (RAPN) and laparoscopic partial nephrectomy (LPN) seems to be significantly better than OPN in terms of perioperative complications, estimated blood loss and hospital stay. Conversely, transfusion rate, ischemia time, change in estimated glomerular filtration rate and early cancer outcomes are similar between the two approaches. International guidelines recommend the use of both approaches according to the surgeon and patient preferences.
so, we are plaining to do the study comparing between RAPN and LPN regarding feasibility and ability of both techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic partial nephrectomy | Other | Procedure: laparoscopic partial nephrectomycases of renal cell carcinoma , localized tumors , candidate for laparoscopic partial nephrectomy |
| robotic partial nephrectomy | Other | Procedure: robotic partial nephrectomycases of renal cell carcinoma , localized tumors , candidate for robotic partial nephrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- renal mass T1 according to TNM amenable for partial nephrectomy.
Key exclusion criteria (4 listed)
- any unfit pt for partial nephrectomy
- more than 7cm tumor
- mass not amenable for partial nephrectomy
- metastatic tumor or locally advanced
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 nephrectomycases amenable for partial nephrectomy | Procedure or surgery | laparoscopic partial nephrectomy |
| robotic partial nephrectomycases amenable for partial nephrectomy | Procedure or surgery | robotic partial nephrectomy |
Primary outcome
to compare between laparoscopic and robotic partial nephrectomy regards ischemia time
Time frame: 1 year
to compare between laparoscopic and robotic partial nephrectomy regards ischemia time
1 secondary outcome
compare between laparoscopic and robotic partial nephrectomy pathological safty margin
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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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.
hossam elsayed kandeel, MSC study director
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic partial nephrectomy and robotic partial nephrectomy in people with Renal Cell Carcinoma, run by Menoufia University at 1 site in Egypt.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hossam elsayed kandeel, MSC (01097991198 ext. 002, hossamkandeel016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare between laparoscopic and robotic partial nephrectomy regards ischemia time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.