Holmium Vs Trilogy Kidney Stones GUY's 1-2

NCT04559321 | Unknown Phase 3 DMC

• 1 other identifier: CI-HRAEB-056-2020
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone; Kidney Calculi; Kidney Diseases

Keywords

Kidney Calculi

Outcome Measures

Primary Outcomes (1)

• Rate of Stone clearance

  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

  10 minutes

Secondary Outcomes (1)

• Complications during surgery

  3 months

Study Arms (2)

Holmium laser

ACTIVE COMPARATOR

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.

Procedure: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.

Trilogy

EXPERIMENTAL

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

Procedure: Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.

Interventions

Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization. PROCEDURE

General anesthesia, Valdivia-Galdakao position, cystoscopy and 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 or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization

Also known as: Trilogy Vs Laser Holmium

Holmium laser; Trilogy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a history of coagulopathies.
• Patients with anatomical abnormalities of the urinary tract.
• Pregnant patients.
• Patients with kidney stones GUY´s 3 and 4.
• 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.

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad del Bajio: lead
• Braulio Omar Manzo Pérez: collaborator
• Edson Dazaeb Flores Hernández: collaborator
• Pompeyo Stalin Alarcón Vigil: collaborator

Study Sites (1)

Hospital Regional de Alta Especilidad del bajio

León, Guanajuato, 37660, Mexico

RECRUITING

Related Publications (9)

• Scotland KB, Kroczak T, Pace KT, Chew BH. Stone technology: intracorporeal lithotripters. World J Urol. 2017 Sep;35(9):1347-1351. doi: 10.1007/s00345-017-2057-x. Epub 2017 Jun 12.

  PMID: 28608192 RESULT

• Vassar GJ, Chan KF, Teichman JM, Glickman RD, Weintraub ST, Pfefer TJ, Welch AJ. Holmium: YAG lithotripsy: photothermal mechanism. J Endourol. 1999 Apr;13(3):181-90. doi: 10.1089/end.1999.13.181.

  PMID: 10360498 RESULT

• Okhunov Z, del Junco M, Yoon R, Labadie K, Lusch A, Ordon M. In vitro evaluation of LithAssist: a novel combined holmium laser and suction device. J Endourol. 2014 Aug;28(8):980-4. doi: 10.1089/end.2014.0111. Epub 2014 May 8.

  PMID: 24707884 RESULT

• Dauw CA, Borofsky MS, York N, Lingeman JE. A Usability Comparison of Laser Suction Handpieces for Percutaneous Nephrolithotomy. J Endourol. 2016 Nov;30(11):1165-1168. doi: 10.1089/end.2016.0203.

  PMID: 27758119 RESULT

• Carlos EC, Wollin DA, Winship BB, Jiang R, Radvak D, Chew BH, Gustafson MR, Simmons WN, Zhong P, Preminger GM, Lipkin ME. In Vitro Comparison of a Novel Single Probe Dual-Energy Lithotripter to Current Devices. J Endourol. 2018 Jun;32(6):534-540. doi: 10.1089/end.2018.0143. Epub 2018 May 11.

  PMID: 29649900 RESULT

• Nottingham CU, Large T, Cobb K, Sur RL, Canvasser NE, Stoughton CL, Krambeck AE. Initial Clinical Experience with Swiss LithoClast Trilogy During Percutaneous Nephrolithotomy. J Endourol. 2020 Feb;34(2):151-155. doi: 10.1089/end.2019.0561. Epub 2019 Nov 12.

  PMID: 31588790 RESULT

• Sabnis RB, Balaji SS, Sonawane PL, Sharma R, Vijayakumar M, Singh AG, Ganpule AP, Desai MR. EMS Lithoclast Trilogy: an effective single-probe dual-energy lithotripter for mini and standard PCNL. World J Urol. 2020 Apr;38(4):1043-1050. doi: 10.1007/s00345-019-02843-2. Epub 2019 Jun 8.

  PMID: 31177306 RESULT

• Wollin DA, Lipkin ME. Emerging Technologies in Ultrasonic and Pneumatic Lithotripsy. Urol Clin North Am. 2019 May;46(2):207-213. doi: 10.1016/j.ucl.2018.12.006.

  PMID: 30961854 RESULT

• Manzo BO, Lozada Hernandez EE, Casale AR, Jimenez CJ, Gomez YR, Galvan JP, Alarcon P, Flores E, Mendez DM, Sanchez HM. Trilogy vs 100 W Ho: YAG Laser for Lithotripsy in Mini-Percutaneous Nephrolithotomy: Superior Stone-Free Rates in a Randomized Controlled Trial. Urology. 2025 Aug;202:18-24. doi: 10.1016/j.urology.2025.04.005. Epub 2025 Apr 8.

  PMID: 40210001 DERIVED

MeSH Terms

Conditions

Kidney Calculi; Kidney Diseases

Condition Hierarchy (Ancestors)

Nephrolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Edgard Efren Dr Lozada Hernandez, Master

  Hospital Regional de Alta Especialidad

  STUDY DIRECTOR

Central Study Contacts

Edgard Efren Dr Lozada Hernandez, Master

CONTACT

+524772672000; edgardlozada@hotmail.com

Braulio Dr Manzo Perez, Dr

CONTACT

+524772672000; braom85@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind. Patient and doctor who performs the statistical analysis will not know which group each patient belongs to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in clinical research

Model Details: 116 cases will be subjected to a simple randomization with a table of random numbers, 58 patients will undergo a percutaneous mini nephrolithotomy and lithotripsy with LithoClast Trilogy EMS; and the remaining 58 will undergo 100W Holmium laser lithotripsy.

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 22, 2020
• Study Start: September 30, 2020
• Primary Completion: September 2, 2021
• Study Completion: September 1, 2022
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: From the beginning of the study to its end
• Access Criteria: Via email, any researcher may request the documents.

Locations

ME (1)