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OpenTrials
Completed

NCT Number: NCT04069013

Standard vs Mini-PCNL for the Treatment of Stone Disease

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

PCNL

Procedure

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

Primary outcomes

  1. Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss

    Time frame: Post-operative day 1

    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

Secondary outcomes

  1. Surgical outcomes

    Time frame: 30 Days

    Discharge time

  2. Complication Rates

    Time frame: 30 Days

    Complication Rates

  3. Renal Pelvis Pressures

    Time frame: Intraoperative

    Intraoperative renal pelvis pressures

  4. Procalcitonin- Inflammatory Markers

    Time frame: Post operative day 1

    Procalcitonin

  5. IL-6 Inflammatory Markers

    Time frame: Post operative day 1

    IL-6

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Columbia University
  • Dartmouth-Hitchcock Medical Center
  • Duke University
  • Massachusetts General Hospital
  • Ohio State University
  • University of British Columbia
  • Vanderbilt University Medical Center

Registry information

Official study title

Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2019
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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