Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06249100 |
| Other study ID # |
MD 351/2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2024 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The use of flexible ureteroscopy and minimally-invasive percutaneous techniques, which
utilize smaller tract sizes, has been established as a way to decrease the invasiveness of
procedures and improve patient outcomes compared to conventional percutaneous nephrolithotomy
(PCNL) and flexible mini-PCNL has emerged as a novel technique previously first as an
auxiliary procedure and then as a standalone technique. This study aims to assess the
feasibility and effectiveness of flexible nephoscopy in improving stone clearance compared to
standard retrograde intrarenal surgery using a flexible ureteroscope.
Description:
Urinary stones are one of the most common rising health concerns around the world.
Urolithiasis is particularly common in high-income countries, with more than 10% of people
suffering from it. Renal stones often manifest as colicky loin pain, often known as renal
colic.
Percutaneous nephrolithotomy (PCNL) is highly recommended by international guidelines as the
primary treatment for renal stones larger than 20 mm. However, for stones ranging from 10 to
20 mm in size, treatment options may include shock wave lithotripsy (SWL), PCNL, or
retrograde intrarenal surgery (RIRS).
Significant advancements have been achieved in surgical techniques recently, leading to the
emergence of minimally invasive percutaneous nephrolithotomy (mini-PCNL) as a viable and
effective treatment option for the removal of large renal and proximal ureteral stones.
In recent years, there has been a consistent reduction in the size of endoscopic instruments.
The primary objective of these tools is to minimize the amount of blood lost during surgery,
lower the occurrence of complications both during and after the operation, and ultimately
reduce the length of hospital stays.
Despite the use of a smaller nephroscope, the rigidity of the mini-nephroscope poses a
limitation in maneuvering into renal calyces at acute angles. This limitation may necessitate
the creation of additional tracts, leading to an increase in morbidity. To tackle this
challenge, a new technique flexible mini-nephroscope has been developed. This innovative
instrument allows for access to all regions of the pelvi-caliceal system through a single
access tract.
Retrograde Intrarenal Surgery (RIRS) is a prominent approach utilized to eliminate kidney
stone disease. In contrast to PCNL, RIRS offers the benefit of utilizing a natural orifice,
thereby eliminating the need for an additional pathway for lithotripsy. Consequently, this
treatment option ensures enhanced safety and facilitates a more favorable postoperative
recovery process.
RIRS has some significant limitations that make it challenging to retrieve a large number of
fragments after the lithotripsy of large stones. Additionally, there is a complicated balance
between irrigation and intrarenal pressure that must be maintained. While continuous rinsing
of renal cavities is necessary to improve visibility, an imbalanced fluid evacuation can lead
to a rise in pressure within the collecting system. Due to these limitations, large stones
cannot be treated with a single RIRS procedure, and multiple sessions may be required. This
exposes the patient to repeated anesthesia and the risk of ureteral damage and stenosis,
making it important to limit operative time and prevent complications.
This study aims to compare the clinical outcome in the form of safety and efficacy between
flexible mini-nephroscopy in minimally-invasive PCNL and retrograde intra-renal surgery in
patients with symptomatic renal stones.
