Standard vs Mini-PCNL for the Treatment of Stone Disease

Last updated: March 20, 2025
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Stones

Treatment

PCNL

Clinical Study ID

NCT04069013
19-589
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

Exclusion

Exclusion Criteria:

  • 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.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: PCNL
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
September 01, 2025

Study Description

This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.

Connect with a study center

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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