PentafectaNCT06969131
Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
A study testing Open Partial Nephrectomy and Laparoscopic Partial Nephrectomy in people with Pentafecta and Laparoscopic, run by South Valley University at 1 site in Egypt.
Trial summary
This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pentafecta, Laparoscopic, Partial Nephrectomy
- What is being tested?
- Open Partial Nephrectomy and Laparoscopic Partial Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 May 2024
- 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
- Age ≥ 18 years.
- Both sexes.
- Patients who diagnosed with clinical T1 or T2a N0M0 renal tumors who were suitable candidates for partial nephrectomy
Who cannot join
- Severe and irreversible coagulopathy.
- Anatomically unfavorable tumor location.
- Extensive encasement of the renal pedicle.
- Diffuse invasion of the renal vein or central collecting system.
- Adjacent organ invasion consistent with stage cT4 disease.
- Regional lymphadenopathy (stage cTxN1), or anticipated retention of less than 20% of total nephron mass.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy.
Read the detailed description
Partial nephrectomy (PN) is widely considered the preferred treatment for clinical T1 (cT1) renal masses, primarily because it preserves kidney function more effectively than radical nephrectomy.
The trifecta metric includes three components: warm ischemia time (WIT) of ≤ 25 minutes or cold ischemia time (CIT) of ≤ 60 minutes, negative surgical margins, and the absence of perioperative major complications. The pentafecta expands upon these criteria by adding two additional parameters: preservation of ≥ 90% of the estimated glomerular filtration rate (eGFR) and no progression in chronic kidney disease (CKD) stage within 12 months postoperatively.
- Conditions
- Pentafecta, Laparoscopic, Partial Nephrectomy, Renal Tumors
- Being tested
- Open Partial Nephrectomy, Laparoscopic 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.
Open Partial NephrectomyProcedure or surgery
Patients underwent open partial nephrectomy.
Laparoscopic Partial NephrectomyProcedure or surgery
Patients underwent laparoscopic partial nephrectomy.
| Study group | Role | What they receive |
|---|---|---|
| Open Partial Nephrectomy | Experimental | Patients underwent open partial nephrectomy. Receives: Procedure: Open Partial Nephrectomy |
| Laparoscopic Partial Nephrectomy | Experimental | Patients underwent laparoscopic partial nephrectomy. Receives: Procedure: Laparoscopic Partial Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictor of pentafecta achievement
Predictor of pentafecta achievement, such as smoking index, was recorded.
Measured: 12 months postoperatively
Secondary outcomes (7)
Amount of blood loss
Amount of blood loss was recorded.
Measured: Intraoperatively
Surgery duration
Surgery duration was recorded.
Measured: Intraoperatively
Length of hospital stay
Length of hospital stay was recorded from admission till the discharge from hospital.
Measured: Till discharge from hospital (Up to one week).
Intraoperative complications
Intraoperative complications were recorded.
Measured: Intraoperatively
Degree of pain
Each patient will be instructed about postoperative pain assessment with the visual analog scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Measured: 24 hours postoperatively
Analgesic requirements
Incidence of required analgesic was recorded.
Measured: 24 hours postoperatively
Incidence of complications following surgery
Incidence of complications following surgery were recorded.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 May 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PentafectaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Ahmad Mohammed Bakheet, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969131
- Sponsor's protocol ID
- SVU/MED/URO016/2/22/5/400
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
- ClinicalTrials.gov ID
- NCT06969131
- Acronym / sponsor ID
- SVU/MED/URO016/2/22/5/400
- Conditions
- Pentafecta, Laparoscopic, Partial Nephrectomy, Renal Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 May 2025 (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.
This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy.
Detailed description
Partial nephrectomy (PN) is widely considered the preferred treatment for clinical T1 (cT1) renal masses, primarily because it preserves kidney function more effectively than radical nephrectomy.
The trifecta metric includes three components: warm ischemia time (WIT) of ≤ 25 minutes or cold ischemia time (CIT) of ≤ 60 minutes, negative surgical margins, and the absence of perioperative major complications. The pentafecta expands upon these criteria by adding two additional parameters: preservation of ≥ 90% of the estimated glomerular filtration rate (eGFR) and no progression in chronic kidney disease (CKD) stage within 12 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Partial Nephrectomy | Experimental | Procedure: Open Partial NephrectomyPatients underwent open partial nephrectomy. |
| Laparoscopic Partial Nephrectomy | Experimental | Procedure: Laparoscopic Partial NephrectomyPatients underwent laparoscopic partial nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Both sexes.
- Patients who diagnosed with clinical T1 or T2a N0M0 renal tumors who were suitable candidates for partial nephrectomy
Key exclusion criteria (6 listed)
- Severe and irreversible coagulopathy.
- Anatomically unfavorable tumor location.
- Extensive encasement of the renal pedicle.
- Diffuse invasion of the renal vein or central collecting system.
- Adjacent organ invasion consistent with stage cT4 disease.
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 |
|---|---|---|
| Open Partial NephrectomyPatients underwent open partial nephrectomy. | Procedure or surgery | Open Partial Nephrectomy |
| Laparoscopic Partial NephrectomyPatients underwent laparoscopic partial nephrectomy. | Procedure or surgery | Laparoscopic Partial Nephrectomy |
Primary outcome
Predictor of pentafecta achievement
Time frame: 12 months postoperatively
Predictor of pentafecta achievement, such as smoking index, was recorded.
7 secondary outcomes
Amount of blood loss
Time frame: Intraoperatively
Surgery duration
Time frame: Intraoperatively
Length of hospital stay
Time frame: Till discharge from hospital (Up to one week).
Intraoperative complications
Time frame: Intraoperatively
Degree of pain
Time frame: 24 hours postoperatively
Analgesic requirements
Time frame: 24 hours postoperatively
Incidence of complications following surgery
Time frame: 12 months postoperatively
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 13 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Pentafecta
Active, not recruitingObservational study
Multimodal Prediction of Postoperative Prognosis After Partial Nephrectomy for Endophytic Renal Cell Carcinoma
Renal Cell Carcinoma, Kidney Neoplasms
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Partial Nephrectomy and Laparoscopic Partial Nephrectomy in people with Pentafecta and Laparoscopic, run by South Valley 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 3 inclusion and 6 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 13 May 2025. 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?
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?
Predictor of pentafecta achievement (time frame: 12 months postoperatively). 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 13 May 2025.