Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05232188 |
| Other study ID # |
NoyanOzluPCNL |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
