Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones. (PCNL)

Multitract PCNL as One Step for Management of Large Renal Stones

Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract

Study Overview

• Status: Not yet recruiting
• Conditions: Staghorn Calculi
• Intervention / Treatment: Procedure: PCNL

Detailed Description

Staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (NCCT) and plain on kidney, ureter, urinary bladder (KUB). An untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis.

Total stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function.

Based on American Urological Association (AUA) guideline, PCNL is the most effective, safest and minimally invasive treatment option compared to open surgery

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Waleed Mahmoud Abbas, M.Sc; Phone Number: +2001009377858; Email: Dr_walidws@yahoo.com
• Study Contact Backup: Name: Mohamed Ali Zarzour, MD; Phone Number: +2001014714142; Email: Dr-mohamedali81@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients more than 18 years old.
2. Patients with staghorn stone (partial, complete).
3. Patients with multiple calyceal calculi which are inaccessible by single tract.

Exclusion Criteria:

1. Patients under 18 years old.
2. Patients with renal anomalies.
3. Patients with only function kidney.
4. Patients with distal ureteric obstruction.
5. Patients with radiolucent stone.
6. Patients with febrile urinary tract infection.
7. Patients with abnormal coagulopathy state.
8. Patients refused to participate in this study.
9. pregnancy.
10. Musculoskeletal deformity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Multitract PCNL patients; Assessment of the multitract PCNL procedure in removal of large renal stones using pneumatic or laser lithotripsy.	Procedure: PCNL; Percutaneous nephrolithotomy ( Extraction of the renal stones using the nephroscope/ Ureteroscope )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Assessment of the instant postoperative stone free rate and after one month from the procedure for all 40 participants using the postoperative non contrast computerized tomography (NCCT )and plain on kidney , ureter, urinary bladder (KUB )	The participants will be followed for one month after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Measuring the postoperative complications rates, classification of the severity of the complications will assess the safety of the procedure.	From the start of the operation and till one month after the patient discharge.
Operative time	Measurment of the time from start of the operation till fixation of nephrostomy tube	Average of three hours
Postoperative pain	Measurment of the postoperative pain score using the Visual analogue scale(VAS) that is divided into mild(1-3), moderate(4-6) and sever(7-10) according to the severity of the pain.	Within 24 hours postoperative and till the patient discharge
Hospital stay	Postoperative hospital stay of the participants till thier discharge	Average of six days

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.
• Romero V, Akpinar H, Assimos DG. Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Rev Urol. 2010 Spring;12(2-3):e86-96.
• Turk C, Petrik A, Sarica K, et al. Urolithiassis. European Association of Urolgy. Accessed: August 23,2019.
• Zhu W, Liu Y, Liu L, Lei M, Yuan J, Wan SP, Zeng G. Minimally invasive versus standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. 2015 Nov;43(6):563-70. doi: 10.1007/s00240-015-0808-y. Epub 2015 Aug 5.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2024
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: January 30, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (ACTUAL): March 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: PCNL
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Nephrolithiasis; Kidney Calculi; Calculi; Staghorn Calculi
• Other Study ID Numbers: Multitract PCNL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No