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

S

South Valley University

Status

Completed

Conditions

Partial Nephrectomy
Laparoscopic
Pentafecta
Renal Tumors

Treatments

Procedure: Open Partial Nephrectomy
Procedure: Laparoscopic Partial Nephrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06969131
SVU/MED/URO016/2/22/5/400

Details and patient eligibility

About

This study aimed to identify predictive factors associated with the achievement of pentafecta outcomes following partial nephrectomy.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

70 participants in 2 patient groups

Open Partial Nephrectomy
Experimental group
Description:
Patients underwent open partial nephrectomy.
Treatment:
Procedure: Open Partial Nephrectomy
Laparoscopic Partial Nephrectomy
Experimental group
Description:
Patients underwent laparoscopic partial nephrectomy.
Treatment:
Procedure: Laparoscopic Partial Nephrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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