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NCT06969131 | COMPLETED | Pentafecta

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

South Valley University

Information provided by (Responsible Party):

Omar Ahmad Mohammed Bakheet

Brief Summary:

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

Condition or disease

Penal

Laparoscopic

Partial Nephrectomy

Renal Tumors

Intervention/treatment

Open Partial Nephrectomy

Laparoscopic Partial Nephrectomy

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 70 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors
Actual Study Start Date : 2022-05-01
Estimated Primary Completion Date : 2024-05-01
Estimated Study Completion Date : 2024-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Current Role of Pentafecta Outcomes in Open and Laparoscopic Partial Nephrectomy for Localized Renal Tumors

Location Details

NCT06969131

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Locations

Not yet recruiting

Egypt, Lies

South Valley university

South Valley, Qena, Egypt, 83523