Safety of Thulium Fiber Laser Litothripsy in the Management of Large Renal Stones (>1000 mm³) and Factors Affecting Treatment Success

NCT ID: NCT07153978

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-06-01

Brief Summary

The aim of this study is to compare the efficacy and safety of Thulium Fiber Laser (TFL) litothripsy according to stone density and the factors affecting success in patients undergoing retrograde intrarenal surgery (RIRS) for renal calculi >1000 mm3. Between November 2023 and December 2024, 81 patients with a stone volume >1000 mm3 who underwent RIRS with TFL in our clinic were prospectively and sequentially evaluated. Stone density of the patients was measured, and expressed in Hounsfield Units (HU). Patients with stone densities <1000 HU and ≥1000 HU were categorized as Groups 1, and 2, respectively. Demographic data, data of intraoperative laser use, stone-free rates (SFRs), the need for a second session of RIRS and complications were recorded. Duration of TFL litothripsy, total energy used, laser ablation speed (mm3/sec), laser ablation efficiency (mm3/J) and laser energy consumption (J/mm3) were calculated. Correlation tests, univariate and multivariate logistic regression tests were used for statistical analysis.

Conditions

Renal Stones; Retrograde Intrarenal Surgery; Thulium Fiber Laser

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Safety and Efficacy of Thulium Fiber Laser for Large Renal Stones

Demographic data (age, gender, body mass index (BMI)), stone characteristics (size, location, Hounsfield Unit (HU) value) and durations of the procedures were recorded. Patients over 18 years of age, with kidney stones larger than 1000 mm³, single or multiple stones and those eligible for RIRS were included in the study. Patients under 18 years of age, those with bleeding diathesis or inability to discontinue anticoagulant/antiaggregant therapy, cases with a history of previous RIRS, individuals who did not attend follow-up visits, patients in whom postoperative residual stone assessment could not be made, or had concomitant bladder or ureteral stones were excluded. SFRs, the need for a second session of RIRS and complications were noted. General anesthesia was used. Rigid ureteroscope was inserted through urethral meatus. 11/13 F ureteral sheath was advanced over guidewire under fluoroscopy. Laser settings varied 0.2J/100Hz to 1J/10Hz based on stone fragility.

Group Type: EXPERIMENTAL

Effectivity of TFL on large renal stone

Intervention Type: DEVICE

While literature studies on TFL have focused on the effect of stone size on laser efficacy parameters, the present study is important as it is a prospective study examining the effects of TFL lithotripsy on SFRs in stones \>1000 mm3.

Interventions

Effectivity of TFL on large renal stone

While literature studies on TFL have focused on the effect of stone size on laser efficacy parameters, the present study is important as it is a prospective study examining the effects of TFL lithotripsy on SFRs in stones \>1000 mm3.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients ≥18 years of age
• Presence of kidney stones larger than 1000 mm³
• Patients with single or multiple kidney stones
• Patients eligible for retrograde intrarenal surgery (RIRS)

Exclusion Criteria

• Patients younger than 18 years
• Pregnant or breastfeeding women
• Patients with uncorrected coagulopathy
• Patients with active urinary tract infection
• Patients with severe anatomic abnormalities preventing RIRS
• Patients unwilling or unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gaziantep

OTHER

Sponsor Role: collaborator

Muharrem Baturu

OTHER

Sponsor Role: lead

Responsible Party

Muharrem Baturu

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Gaziantep

Gaziantep, Şehitkamil, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TF.ALT.23.10

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023/06

Identifier Type: -

Identifier Source: org_study_id