Standard vs Mini-PCNL for the Treatment of Stone Disease
Primary Purpose
Urolithiasis, Kidney Stone, Kidney Calculi
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCNL
Sponsored by
About this trial
This is an interventional treatment trial for Urolithiasis focused on measuring Percutaneous Nephrolithotomy, PCNL
Eligibility 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.
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard PCNL
Mini-PCNL
Arm Description
Patients receive a standard PCNL procedure using a 24 fr tract
Patients receive a mini-PCNL procedure using a 16 fr tract
Outcomes
Primary Outcome Measures
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss
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
Surgical outcomes
Discharge time
Complication Rates
Complication Rates
Renal Pelvis Pressures
Intraoperative renal pelvis pressures
Procalcitonin- Inflammatory Markers
Procalcitonin
IL-6 Inflammatory Markers
IL-6
Full Information
NCT ID
NCT04069013
First Posted
August 15, 2019
Last Updated
May 19, 2021
Sponsor
The Cleveland Clinic
Collaborators
University of British Columbia, Massachusetts General Hospital, Vanderbilt University Medical Center, Duke University, Ohio State University, Columbia University, Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04069013
Brief Title
Standard vs Mini-PCNL for the Treatment of Stone Disease
Official Title
Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
University of British Columbia, Massachusetts General Hospital, Vanderbilt University Medical Center, Duke University, Ohio State University, Columbia University, Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis, Kidney Stone, Kidney Calculi, Ureteral Calculi, Kidney Diseases
Keywords
Percutaneous Nephrolithotomy, PCNL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard PCNL
Arm Type
Active Comparator
Arm Description
Patients receive a standard PCNL procedure using a 24 fr tract
Arm Title
Mini-PCNL
Arm Type
Active Comparator
Arm Description
Patients receive a mini-PCNL procedure using a 16 fr tract
Intervention Type
Procedure
Intervention Name(s)
PCNL
Intervention Description
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL
Primary Outcome Measure Information:
Title
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss
Description
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
Time Frame
Post-operative day 1
Secondary Outcome Measure Information:
Title
Surgical outcomes
Description
Discharge time
Time Frame
30 Days
Title
Complication Rates
Description
Complication Rates
Time Frame
30 Days
Title
Renal Pelvis Pressures
Description
Intraoperative renal pelvis pressures
Time Frame
Intraoperative
Title
Procalcitonin- Inflammatory Markers
Description
Procalcitonin
Time Frame
Post operative day 1
Title
IL-6 Inflammatory Markers
Description
IL-6
Time Frame
Post operative day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manoj Monga, MD
Phone
216-445-8678
Email
mongam@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Naveen Kachroo, MD
Phone
216-973-5227
Email
kachron@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Monga, MD
Phone
216-445-8678
Email
mongam@ccf.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Standard vs Mini-PCNL for the Treatment of Stone Disease
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