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Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors

The Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06969131
Enrollment
70
Registered
2025-05-13
Start date
2022-05-01
Completion date
2024-05-01
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic, Partial Nephrectomy, Pentafecta, Renal Tumors

Brief summary

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.

Interventions

Patients underwent open partial nephrectomy.

Patients underwent laparoscopic partial nephrectomy.

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years. * Both sexes. * Patients who diagnosed with clinical T1 or T2a N0M0 renal tumors who were suitable candidates for partial nephrectomy

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Predictor of pentafecta achievement12 months postoperativelyPredictor of pentafecta achievement, such as smoking index, was recorded.

Secondary

MeasureTime frameDescription
Surgery durationIntraoperativelySurgery duration was recorded.
Length of hospital stayTill discharge from hospital (Up to one week).Length of hospital stay was recorded from admission till the discharge from hospital.
Intraoperative complicationsIntraoperativelyIntraoperative complications were recorded.
Amount of blood lossIntraoperativelyAmount of blood loss was recorded.
Analgesic requirements24 hours postoperativelyIncidence of required analgesic was recorded.
Incidence of complications following surgery12 months postoperativelyIncidence of complications following surgery were recorded.
Degree of pain24 hours postoperativelyEach 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026