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Standard vs Mini-PCNL for the Treatment of Stone Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069013
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
University of British Columbia
Massachusetts General Hospital
Vanderbilt University Medical Center
Duke University
Ohio State University
Columbia University
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Urolithiasis Kidney Stone Kidney Calculi Ureteral Calculi Kidney Diseases Procedure: PCNL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069013


Contacts
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Contact: Manoj Monga, MD 216-445-8678 mongam@ccf.org
Contact: Naveen Kachroo, MD 216-973-5227 kachron@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Contact: Manoj Monga, MD    216-445-8678    mongam@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
University of British Columbia
Massachusetts General Hospital
Vanderbilt University Medical Center
Duke University
Ohio State University
Columbia University
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Manoj Monga, MD The Cleveland Clinic
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04069013    
Other Study ID Numbers: 19-589
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
Percutaneous Nephrolithotomy
PCNL
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Calculi
Nephrolithiasis
Urolithiasis
Ureteral Calculi
Ureterolithiasis
Calculi
Urologic Diseases
Pathological Conditions, Anatomical
Urinary Calculi
Ureteral Diseases