Standard vs Mini-PCNL for the Treatment of Stone Disease

January 5, 2026 updated by: The Cleveland Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard PCNL
Patients receive a standard PCNL procedure using a 24 fr tract
Procedure: PCNL
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL
Active Comparator: Mini-PCNL
Patients receive a mini-PCNL procedure using a 16 fr tract
Procedure: PCNL
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Post-operative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical outcomes
Time Frame: 30 Days
Discharge time
30 Days
Complication Rates
Time Frame: 30 Days
Complication Rates
30 Days
Renal Pelvis Pressures
Time Frame: Intraoperative
Intraoperative renal pelvis pressures
Intraoperative
Procalcitonin- Inflammatory Markers
Time Frame: Post operative day 1
Procalcitonin
Post operative day 1
IL-6 Inflammatory Markers
Time Frame: Post operative day 1
IL-6
Post operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

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

Investigators

  • Principal Investigator: Manoj Monga, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Actual)

November 11, 2025

Study Completion (Actual)

November 11, 2025

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 23, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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