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Mini-PNCL vs fURS in Management of Nephrolithiasis

Primary Purpose

Nephrolithiasis, Kidney Stone

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Flexible ureteroscopy
Mini-percutaneous nephrolithotomy
Sponsored by
Thunder Bay Regional Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis

Eligibility Criteria

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

Inclusion Criteria:

  1. Male and female subjects over 18 years of age at the time of enrollment.
  2. Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
  3. Written informed consent to participate in the study
  4. Ability to comply with the requirements of the study procedures

Exclusion Criteria:

  1. Congenital anatomic anomalies of the kidney, ureters or bladder.
  2. Previous ipsilateral renal surgery within past five years.
  3. Patients with ipsilateral distal ureteral stones or stricture.
  4. Stone size > 20 mL or multiple kidney stones in different calyces.
  5. Previous SWL treatment for the same stone.
  6. Patients presented with a previously inserted ipsilateral ureteral stent.
  7. Participants with active urinary tract infection until appropriately treated
  8. Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
  9. Pregnancy or morbid obesity
  10. Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
  11. Participants who are uncooperative or cannot follow instructions.
  12. Participants who lack the capacity to provide free and informed written consent.
  13. Patients with solitary kidney.

Sites / Locations

  • Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Flexible ureteroscopy (fURS)

Mini-percutaneous nephrolithotomy (mini-PCNL)

Arm Description

Retrograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.

PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs)4

Outcomes

Primary Outcome Measures

Stone-free status
Operation success will be evaluated with a non-contrast computed tomography (CT) scan on the first post-operative day, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan
Stone-free status
Operation success will be re-evaluated with a non-contrast computed tomography (CT) scan at 4-weeks post-operation, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan

Secondary Outcome Measures

To compare safety measures
Adverse events including perioperative bleeding, operative time, fluoroscopy time, need for blood transfusion, stone composition, fragmentation type, ureteral stenting, and urinary tract infection will be recorded intra and post-op
To compare stone free status of single use vs reusable fURS
Subgroup analysis comparing two types of fURS treatments. In this study, participants randomized to the fURS cohort may receive either single use or reusable fURS are their standard of care treatment. The investigators plan to conduct a subgroup analysis comparing stone-free status 1-day post-op using a standard of care non-contrast CT scan.
To compare stone free status of single use vs reusable fURS
Subgroup analysis comparing two types of fURS treatments. In this study, participants randomized to the fURS cohort may receive either single use or reusable fURS are their standard of care treatment. The investigators plan to conduct a subgroup analysis comparing stone-free status 4-weeks post-op using a standard of care non-contrast CT scan.
Assess the postoperative pain between both techniques
Post-surgical pain will be assessed using a Visual Analog Scale (VAS) questionnaire. This questionnaire consists of 1 question asking participants to choose a number from 0-10 describing their pain at the current moment. A lower score indicates less pain, while a higher score indicates a higher degree of pain. For example a score of 0 indicates "No Pain", while a score of 10 indicates "Unbearable Pain".
Assess the postoperative pain between both techniques
Post-surgical pain will be assessed using a Visual Analog Scale (VAS) questionnaire. This questionnaire consists of 1 question asking participants to choose a number from 0-10 describing their pain at the current moment. A lower score indicates less pain, while a higher score indicates a higher degree of pain. For example a score of 0 indicates "No Pain", while a score of 10 indicates "Unbearable Pain".

Full Information

First Posted
May 5, 2020
Last Updated
October 18, 2022
Sponsor
Thunder Bay Regional Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04389853
Brief Title
Mini-PNCL vs fURS in Management of Nephrolithiasis
Official Title
Ambulatory Tubeless Mini Percutaneous Nephrolithotomy Versus Retrograde Intrarenal Surgery in the Management of Nephrolithiasis: A Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thunder Bay Regional Health Research Institute

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
The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with retrograde intrarenal surgery (RIRS) and mini-PCNL (miniperc) both demonstrated to be safe and effective methods for treating LPS with a diameter of 1-2 cm. Selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates. To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This will decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol.
Detailed Description
The prevalence of nephrolithiasis is increasing over the last two decades, and kidney stones is a recurrent disorder, with lifetime recurrence risks reported to be as high as 50%. One of the most challenging stones is the lower pole (LP) nephrolithiasis. This could be explained by its antigravity location, acute angle with the renal pelvis and the narrow angle of the infundibulum. Therefore, the optimal management of LP calculi continues to be a dilemma. The standard management of lower pole stones (LPS), is still controversial especially for stones smaller than 20 mm, with competing interventions possessing advantages and disadvantages. Treatment options include percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), or shockwave lithotripsy (SWL). PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, surgeons have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs). Another alternative option is RIRS. RIRS has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding. RIRS and miniperc are both safe and effective methods for treating LPS with a diameter of 1-2 cm. The SFRs were comparable at the first postoperative day (90.2% vs. 93.2%) and the second month postoperatively (93.8% vs. 95.1%), for RIRS and miniperc, respectively. However, miniperc was associated with significant longer hospital stay and higher hospitalization costs. Therefore, selecting the optimal modality for treating renal calculi is challenging, as both techniques may be associated with different patient benefits and risk profiles. Despite the evolution of mini-PCNL and fURS techniques into clinical practice, there is a lack of comparative clinical data assessing SFRs and complication rates. To the investigators' knowledge, no previous studies have addressed the outcome of ambulatory tubeless miniperc as a same day procedure, which this study will look to assess. The investigators are planning to discharge all participants home the night of surgery, without admission or insertion of nephrostomy tube. This should decrease the morbidity of miniperc and encourage head-to-head comparison with fURS in a prospective randomized protocol. The investigators will attempt to address whether there is a difference in clinical outcome between ambulatory mini percutaneous nephrolithotomy and flexible ureteroscopy in the management of lower pole kidney stones?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis, Kidney Stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Study comparing two standard of care treatments.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flexible ureteroscopy (fURS)
Arm Type
Active Comparator
Arm Description
Retrograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.
Arm Title
Mini-percutaneous nephrolithotomy (mini-PCNL)
Arm Type
Active Comparator
Arm Description
PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs)4
Intervention Type
Procedure
Intervention Name(s)
Flexible ureteroscopy
Intervention Description
Retograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.
Intervention Type
Procedure
Intervention Name(s)
Mini-percutaneous nephrolithotomy
Intervention Description
PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs).
Primary Outcome Measure Information:
Title
Stone-free status
Description
Operation success will be evaluated with a non-contrast computed tomography (CT) scan on the first post-operative day, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan
Time Frame
1-day
Title
Stone-free status
Description
Operation success will be re-evaluated with a non-contrast computed tomography (CT) scan at 4-weeks post-operation, as per standard of care. Presence or absence of kidney stones will be confirmed via CT scan
Time Frame
4-weeks post-op
Secondary Outcome Measure Information:
Title
To compare safety measures
Description
Adverse events including perioperative bleeding, operative time, fluoroscopy time, need for blood transfusion, stone composition, fragmentation type, ureteral stenting, and urinary tract infection will be recorded intra and post-op
Time Frame
4 weeks
Title
To compare stone free status of single use vs reusable fURS
Description
Subgroup analysis comparing two types of fURS treatments. In this study, participants randomized to the fURS cohort may receive either single use or reusable fURS are their standard of care treatment. The investigators plan to conduct a subgroup analysis comparing stone-free status 1-day post-op using a standard of care non-contrast CT scan.
Time Frame
1-day post-op
Title
To compare stone free status of single use vs reusable fURS
Description
Subgroup analysis comparing two types of fURS treatments. In this study, participants randomized to the fURS cohort may receive either single use or reusable fURS are their standard of care treatment. The investigators plan to conduct a subgroup analysis comparing stone-free status 4-weeks post-op using a standard of care non-contrast CT scan.
Time Frame
4-weeks post-op
Title
Assess the postoperative pain between both techniques
Description
Post-surgical pain will be assessed using a Visual Analog Scale (VAS) questionnaire. This questionnaire consists of 1 question asking participants to choose a number from 0-10 describing their pain at the current moment. A lower score indicates less pain, while a higher score indicates a higher degree of pain. For example a score of 0 indicates "No Pain", while a score of 10 indicates "Unbearable Pain".
Time Frame
1-day post-op
Title
Assess the postoperative pain between both techniques
Description
Post-surgical pain will be assessed using a Visual Analog Scale (VAS) questionnaire. This questionnaire consists of 1 question asking participants to choose a number from 0-10 describing their pain at the current moment. A lower score indicates less pain, while a higher score indicates a higher degree of pain. For example a score of 0 indicates "No Pain", while a score of 10 indicates "Unbearable Pain".
Time Frame
4-weeks post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects over 18 years of age at the time of enrollment. Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx. Written informed consent to participate in the study Ability to comply with the requirements of the study procedures Exclusion Criteria: Congenital anatomic anomalies of the kidney, ureters or bladder. Previous ipsilateral renal surgery within past five years. Patients with ipsilateral distal ureteral stones or stricture. Stone size > 20 mL or multiple kidney stones in different calyces. Previous SWL treatment for the same stone. Patients presented with a previously inserted ipsilateral ureteral stent. Participants with active urinary tract infection until appropriately treated Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery). Pregnancy or morbid obesity Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Participants who are uncooperative or cannot follow instructions. Participants who lack the capacity to provide free and informed written consent. Patients with solitary kidney.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Malik, MSc
Phone
(807) 684-6000
Ext
6608
Email
maliki@tbh.net
First Name & Middle Initial & Last Name or Official Title & Degree
Shalyn Littlefield, MSc
Phone
(807) 684-6000
Ext
6608
Email
littlefs@tbh.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem Elmansy, MD
Organizational Affiliation
Thunder Bay Regional Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B6V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Malik, MSc
Phone
(807) 684-6000
Ext
6608
Email
maliki@tbh.net
First Name & Middle Initial & Last Name & Degree
Shalyn Littlefield, MSc
Phone
(807) 684-6000
Ext
6608
Email
littlefs@tbh.net
First Name & Middle Initial & Last Name & Degree
Hazem Elmansy, MD
First Name & Middle Initial & Last Name & Degree
Walid Shahrour, MD
First Name & Middle Initial & Last Name & Degree
Ahmed Kotb, MD
First Name & Middle Initial & Last Name & Degree
Owen Prowse, MD
First Name & Middle Initial & Last Name & Degree
Fabiola Oquendo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share participant data with other researchers. Findings may be presented locally, nationally, and internationally at conferences. Any data presented will be de-identified and grouped prior to use, as to protect participant confidentiality.

Learn more about this trial

Mini-PNCL vs fURS in Management of Nephrolithiasis

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