Standard vs Mini-PCNL for the Treatment of Stone Disease

NCT ID: NCT04069013

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-11-11

Brief Summary

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

Detailed Description

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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.

Conditions

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Urolithiasis Kidney Stone Kidney Calculi Ureteral Calculi Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard PCNL

Patients receive a standard PCNL procedure using a 24 fr tract

Group Type ACTIVE_COMPARATOR

PCNL

Intervention Type PROCEDURE

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

Mini-PCNL

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

Group Type ACTIVE_COMPARATOR

PCNL

Intervention Type PROCEDURE

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

Interventions

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PCNL

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manoj Monga, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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19-589

Identifier Type: -

Identifier Source: org_study_id

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