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

NCT ID: NCT06969131

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

Pentafecta; Laparoscopic; Partial Nephrectomy; Renal Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Partial Nephrectomy

Patients underwent open partial nephrectomy.

Group Type: EXPERIMENTAL

Open Partial Nephrectomy

Intervention Type: PROCEDURE

Patients underwent open partial nephrectomy.

Laparoscopic Partial Nephrectomy

Patients underwent laparoscopic partial nephrectomy.

Group Type: EXPERIMENTAL

Laparoscopic Partial Nephrectomy

Intervention Type: PROCEDURE

Patients underwent laparoscopic partial nephrectomy.

Interventions

Open Partial Nephrectomy

Patients underwent open partial nephrectomy.

Intervention Type: PROCEDURE

Laparoscopic Partial Nephrectomy

Patients underwent laparoscopic partial nephrectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Omar Ahmad Mohammed Bakheet

Assistant Lecturer of Urology, Faculty of Medicine, South Valley University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South Valley university

South Valley, Qena Governorate, Egypt

Countries

Egypt

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id