Safety and Effectiveness of Antegrade Flexible Ureteroscopy-Assisted Percutaneous Nephrolithotomy for Staghorn Calculi

NCT07172373 | Not Yet Recruiting DMC

• 1 other identifier: 062/2025
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective This study aims to evaluate the safety and efficacy of antegrade flexible ureteroscopy-assisted PCNL for the treatment of staghorn calculi, compared with standard PCNL. Methods This prospective, multicenter, randomized controlled trial plans to enroll 420 patients with staghorn calculi, randomly assigned into two groups: the experimental group (antegrade flexible ureteroscopy-assisted PCNL, n=210) and the control group (standard PCNL, n=210). The primary endpoint is stone-free rate (defined as no residual fragment ≥2 mm on postoperative CT). Secondary endpoints include operative time, number of percutaneous tracts, rate of secondary procedures, hemoglobin decrease, postoperative complications (Clavien-Dindo classification), and length of hospital stay. All patients will undergo CT evaluation on postoperative day 2. Subgroup analysis will be performed according to the number of stone branches (≥5 vs \<5).

Conditions

Urolithiasis; Renal Stones

Keywords

Percutaneous nephrolithotomy; Antegrade flexible ureteroscopy; Staghorn calculi; Stone branch number

Outcome Measures

Primary Outcomes (1)

• Immediately stone-free rate (SFR)

  defined as no residual fragment ≥2 mm on postoperative CT

  On postoperative day 2, a non-contrast CT of the urinary system will be performed, and the absence of residual fragments larger than 2 mm will be defined as stone-free.

Secondary Outcomes (3)

• Operative time

  From the establishment of the first percutaneous renal tract to the placement of the final nephrostomy tube.

• Duration of hospital stay

  Up to 3 months.

• Complications

  Up to 3 months.

Study Arms (2)

antegrade flexible ureteroscopy-assisted PCNL

EXPERIMENTAL

antegrade flexible ureteroscopy-assisted PCNL

Procedure: antegrade flexible ureteroscopy-assisted PCNL

single PCNL

OTHER

single PCNL

Procedure: single PCNL

Interventions

antegrade flexible ureteroscopy-assisted PCNL PROCEDURE

antegrade flexible ureteroscopy-assisted PCNL

antegrade flexible ureteroscopy-assisted PCNL

single PCNL PROCEDURE

single PCNL

single PCNL

Eligibility Criteria

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

You may qualify if:

• Staghorn calculi confirmed by non-contrast CT of the urinary system; Age ≥18 years; General condition suitable for surgical treatment; Ability to understand and voluntarily sign the informed consent form.

You may not qualify if:

• Solitary kidney or congenital anomalies (such as horseshoe kidney or ectopic kidney); Patients with severe preoperative pyelonephritis; Patients with psychiatric disorders or unwilling to cooperate; Patients with uncontrolled diabetes or hypertension who cannot tolerate surgery; Patients with coagulation disorders; Patients deemed unsuitable for participation in this trial by the investigator.

Sponsors & Collaborators

• Tianjin Medical University Second Hospital: lead
• Chinese PLA General Hospital: collaborator
• Tianjin Medical University General Hospital: collaborator
• Peking University People's Hospital: collaborator
• First Hospital of China Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Beijing Tsinghua Changgeng Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Wuhan TongJi Hospital: collaborator

MeSH Terms

Conditions

Urolithiasis; Nephrolithiasis; Staghorn Calculi

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yuanjiong Qi

CONTACT

022-88328695; qiyuanjiong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Because of the inherent differences between the two interventions, blinding of patients and surgeons is not feasible. Postoperative imaging (CT) will be evaluated by radiologists blinded to treatment allocation, and clinical outcomes will be assessed by investigators who were not involved in the surgeries and remained unaware of the intervention. In addition, statistical analyses will be conducted in a blinded manner, with analysts kept unaware of group assignments until all analyses and interpretations are completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share