Effect of Renal Access Sheath on Functions

The Effect of Renal Access Sheath Size Used During Percutaneous Nephrolithotomy on Postoperative Renal Functions

Patients will be randomly divided into two groups in order to evaluate the effect of the size of the access sheath (Amplatz) used in the Percutaneous Nephrolithotomy (PCNL) operation on kidney functions. After dilatation, 22French (Fr) Amplatz sheath will be placed in the first group, while 28Fr Amplatz sheath will be placed in the second group.

The functional difference will be evaluated with preoperative and postoperative 3rd-month kidney scintigraphies (diethylenetriamine pentaacetic acid (DTPA) and technetium-99m dimercaptosuccinic acid (DMSA). In addition, Kidney Injury Molecule-1 (KIM-1) levels will be measured in the urine in order to be a predictor of functional loss in the early period.

Study Overview

• Status: Active, not recruiting
• Conditions: Treatment Outcome; Kidney Function Tests
• Intervention / Treatment: Procedure: Percutaneous nephrolithotomy

Detailed Description

PCNL has been applied for the last 30 years as the primary and most effective treatment method in patients with kidney stones of 2 cm or larger. The primary purpose of the operation is to ensure stone-freeness. Another aim is to keep the damage to kidney functions to a minimum, thanks to the endoscopic intervention. In this respect, PCNL is superior to open surgery and reduces morbidity.

Renal access, dilatation, and fragmentation are the 3 important stages of the operation, and access and dilation significantly affect the final results of PCNL. The size of the access sheath used as a result of dilation determines the size of the tract where the endoscopic intervention will be made, and not only affects the postoperative results and success but also determines the factors that may affect the kidney functions such as bleeding and loss of parenchyma in the kidney.

There are studies showing that less bleeding, shorter hospital stay, and better postoperative pain control are achieved with the reduction of access sheath size. In addition to conventional PCNL, methods such as mini PCNL, micro PCNL, ultra-mini PCNL, and tubeless PCNL, where the diameter of the access sheath and endoscope are gradually decreasing, both increase success and reduce morbidity.

In our study, in order to examine the postoperative functional results of 22 Fr and 28 Fr accessory sheath size;

• For the early period, the change in KIM-1 values, a validated biomarker in acute kidney injury, measured on the preoperative and postoperative day 1 will be proportioned between the groups,
• For the late period, we aimed to compare the kidney functions in the mid-long term by proportioning the DMSA and DTPA values at the preoperative and postoperative 3rd month.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bakırköy Dr. Sadi Konuk Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with 2-3 cm kidney stones
• Patients with an American Society of Anesthesiologists ≤2 score
• BMI: Patients between 20 and 35 kg/m2

Exclusion Criteria:

• Patients with preoperative renal failure
• Patients with multiple access
• Patients undergone renal transplantation
• Patients with renal anomalies (horseshoe kidney, solitary kidney, double collecting system, etc.)
• Patients with history of open kidney stones surgery and/or PCNL history
• Patients who cannot be stone-free in the postoperative period (fragments >4 mm in imaging) and require additional treatment intervention
• Patients with bleeding disorders
• Pregnant patients
• Patients with complete staghorn stones
• Patients with bilateral obstructive stones
• Patients with active infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 22French (Fr); After renal access, dilatation is provided up to 22Fr with a dilatator set, and fragmentation is started with a 19Fr nephroscope.	Procedure: Percutaneous nephrolithotomy; percutaneous nephrolithotomy surgery, 22F amplatz sheath is used in one group, while 28F amplatz sheath is used in the other group.
Experimental: 28F; After renal access, dilatation is provided up to 28Fr with a dilatator set, and fragmentation is started with a 25Fr nephroscope.	Procedure: Percutaneous nephrolithotomy; percutaneous nephrolithotomy surgery, 22F amplatz sheath is used in one group, while 28F amplatz sheath is used in the other group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differential function changes	Differential function changes in the operated kidney in postoperative DMSA and DTPA	3 months
Newly developed scar	Presence of newly developed scar in DMSA	3 months
KIM-1	Change in urinary KIM-1 levels	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatinine	Postoperative changes in creatinine	24 hours
Glomerular filtration rate	Postoperative changes in glomerular filtration rate	24 hours
Stone-free rate	Postoperative stone-free rates	24 hours
Complications	Complications according to Clavian grading	30 days

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous nephrolithotomy; Amplatz sheath
• Other Study ID Numbers: NoyanOzluPCNL

Drug and device information, study documents

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