Effect of Renal Access Sheath on Functions

Treatment Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05232188
• Other study ID #: NoyanOzluPCNL
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: December 2022
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Function Tests
• Treatment Outcome

Intervention

Procedure:
• Percutaneous nephrolithotomy
percutaneous nephrolithotomy surgery, 22F amplatz sheath is used in one group, while 28F amplatz sheath is used in the other group.

Locations

Country	Name	City	State
Turkey	Bakirköy Dr. Sadi Konuk Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential function changes	Differential function changes in the operated kidney in postoperative DMSA and DTPA	3 months
Primary	Newly developed scar	Presence of newly developed scar in DMSA	3 months
Primary	KIM-1	Change in urinary KIM-1 levels	24 hours
Secondary	Creatinine	Postoperative changes in creatinine	24 hours
Secondary	Glomerular filtration rate	Postoperative changes in glomerular filtration rate	24 hours
Secondary	Stone-free rate	Postoperative stone-free rates	24 hours
Secondary	Complications	Complications according to Clavian grading	30 days