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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
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis focused on measuring Percutaneous Nephrolithotomy, PCNL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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