Comparison of the 100 W Holmium Laser Lithotripsy Rate Versus LithoClast Trilogy EMS in Percutaneous Mini-nephrolithotomy for Patients With Kidney Stones GUY's 1 and 2: Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Rate of Stone clearance
Study Overview
Brief Summary
The desire to reduce complications related to percutaneous access and morbidity related to tract size has led researchers to evaluate PCNL using smaller-caliber instruments. In this context, mini-PCNL has emerged. Its efficacy and safety have been demonstrated at the cost of a lower stone-free rate.
The effectiveness of existing Ho: YAG lasers is limited by the need for manual removal of stone fragments and mobilization of them due to the lack of a simultaneous aspiration system. Consequently, this has been associated with long surgical times to achieve stone-free status. This requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all fragments. This repeated step can cause the safety rails to be inadvertently removed or the sheaths to be disinserted. Sometimes compromising surgical results.
Faced with this situation, the search for better and more efficient energy sources still continues. With this, modern lithotripters have emerged that combine energy sources and work more efficiently than any of them independently and, consequently, improve stone removal. Cyberwand ™ (Olympus, Tokyo, Japan), Swiss Lithoclast® Master / Select (EMS SA, Switzerland / Boston Scientific, Marlborough, MA, USA) and Shockpulse-SE ™ (Olympus, Tokyo, Japan) are some examples; although they have their own set of advantages, none have proven to be superior to any other.
As previously discussed, ballistic-ultrasonic lithotripsy combines ultrasonic and ballistic energy together with a suction system with encouraging results in terms of a shorter lithotripsy time and the respective economic impact of fewer surgical events and less operating time required for the stone removal.
Therefore, it is convenient to make a comparison between the results of lithotripsy with Ho: YAG laser energy and lithotripsy with LithoClast Trilogy EMS; and thereby determine which is the most effective method in the resolution of kidney stones through a miniaturized percutaneous tract.
Detailed Description
Background The tools used for fragmentation and stone extraction have been improving over time. Commonly available lithotripsy power sources are classified as ultrasonic, kinetic, electrohydraulic, or combination, however, laser is the most widely used lithotripsy device in mini-PCNL as it is a small diameter power source.
Laser lithotripsy The holmium laser has been very effective in the fragmentation of stones of variable hardness and very safe due to its low depth of penetration (0.5 mm).
One of the advantages of the Ho: YAG laser is that it offers relatively quick lithotripsy while minimizing tissue trauma. Furthermore, it is effective against all stone compositions, including cystine and calcium oxalate monohydrate, where ultrasonic lithotripsy may have difficulties.
The removal of smaller fragments is possible using a vacuum effect where the fragments are moved from a high pressure zone in the pyelocaliceal system to a lower pressure zone in the sheath. If there are too many fragments, this requires multiple insertions and extractions of the nephroscope to facilitate the recovery of all of them. This repeated step can cause inadvertent movements that affect the results.
Combined ballistic-ultrasonic lithotripsy LithoClast Trilogy EMS is the newest model of percutaneous lithotripsy technology that provides electromagnetic and ultrasonic ballistic energy, as well as suction capacity under the control of the surgeon through a single pedal. Laboratory studies have suggested that combined ballistic-ultrasonic lithotripsy offers faster stone clearance than other combined and ultrasonic devices. In an in vitro comparison, LithoClast Trilogy EMS had the fastest average removal time of 23.79 seconds. This was followed by ShockPulse (46.04 seconds), Select-US (54.86 seconds), and Select-USP (102.48 seconds).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Double-blind. Patient and doctor who performs the statistical analysis will not know which group each patient belongs to.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients older than 18 years
- •Diagnosis of GUY´s kidney stones 1 and 2 who will undergo a percutaneous mini nephrolithotomy
- •Preoperative serum hemoglobin> 10 g / dl
- •Preoperative serum creatinine <1.5 mg / dl.
- •Surgical risk I-III according to "American Society of Anesthesiologists".
- •Previous negative urine culture.
- •With postoperative follow-up with computed tomography at three months.
- •Patients who are not participating in another project related to the treatment of lithiasis -Who have signed an informed consent where they agree to be part of the study.
Exclusion Criteria
- •Patients with a history of coagulopathies.
- •Patients with anatomical abnormalities of the urinary tract.
- •Pregnant patients.
- •Patients with kidney stones GUY´s 3 and
- •Patients who do not wish to participate in the clinical trial.
- •Patient who due to their physical and / or mental state are not able to sign the informed consent.
- •Elimination criteria. Patients who have lost follow-up in the first three months after treatment.
Arms & Interventions
Holmium laser
General anesthesia, Valdivia-Galdakao position, cystoscopy will be performed, ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with 100 W Holmium laser.
Intervention: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization. (Procedure)
Trilogy
General anesthesia, Valdivia-Galdakao position, cystoscopy will be performed, ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with LithoClast Trilogy EMS and 1.5 mm x 440 mm probe
Intervention: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization. (Procedure)
Outcomes
Primary Outcomes
Rate of Stone clearance
Time Frame: 10 minutes
defined as the kidney stone surface area in square millimeters measured by pre-operative computed tomography scan divided by the time to remove the targeted stone burden in minutes
Secondary Outcomes
- Complications during surgery(3 months)
Investigators
Edgard Lozada
Master in clinical research
Hospital Regional de Alta Especialidad del Bajio