Standard vs Mini-PCNL for the Treatment of Stone Disease

NCT04069013 | Completed

• 1 other identifier: 19-589
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.

Conditions

Urolithiasis; Kidney Stone; Kidney Calculi; Ureteral Calculi; Kidney Diseases

Keywords

Percutaneous Nephrolithotomy; PCNL

Outcome Measures

Primary Outcomes (1)

• Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss

  Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Post-op decreases in hemoglobin

  Post-operative day 1

Secondary Outcomes (5)

• Surgical outcomes

  30 Days

• Complication Rates

  30 Days

• Renal Pelvis Pressures

  Intraoperative

• Procalcitonin- Inflammatory Markers

  Post operative day 1

• IL-6 Inflammatory Markers

  Post operative day 1

Study Arms (2)

Standard PCNL

ACTIVE COMPARATOR

Patients receive a standard PCNL procedure using a 24 fr tract

Procedure: PCNL

Mini-PCNL

ACTIVE COMPARATOR

Patients receive a mini-PCNL procedure using a 16 fr tract

Procedure: PCNL

Interventions

PCNL PROCEDURE

Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL

Mini-PCNL; Standard PCNL

Eligibility Criteria

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

You may qualify if:

• Patients planned for PCNL at participating institutions
• Age ≥ 18 years old
• Male and female patients
• Patients of all ethnic backgrounds
• Stone size 10-20mm
• Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.

You may not qualify if:

• Conversion to open procedure
• Multiple access tracts
• Anticoagulated or history of coagulopathy
• Preoperative ureteral stent or nephrostomy tube placement
• Technical problems/impossibility of localizing the stone on the day of intervention
• Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• University of British Columbia: collaborator
• Massachusetts General Hospital: collaborator
• Vanderbilt University Medical Center: collaborator
• Duke University: collaborator
• Ohio State University: collaborator
• Columbia University: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Urolithiasis; Kidney Calculi; Ureteral Calculi; Kidney Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Manoj Monga, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 28, 2019
• Study Start: May 1, 2022
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)