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Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis

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ClinicalTrials.gov Identifier: NCT05993546
Recruitment Status : Recruiting
First Posted : August 15, 2023
Last Update Posted : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:
The purpose of this study is to compare two variations of the mini-PCNL procedure using either a vacuum-assisted sheath or standard sheath which are both used for the surgical treatment of kidney stones. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Condition or disease Intervention/treatment Phase
Kidney Stone Device: vacuum assisted sheath Device: passive suction via conventional sheath Not Applicable

Detailed Description:

In this study we aim to compare two variations of the miniaturized percutaneous nephrolithotomy (Mini-PCNL) procedure which are both used for the surgical treatment of kidney stones. This procedure involves accessing the kidney via a small temporary tract that is placed through the patient's back during surgery. Both procedure types are commonly used in the treatment of kidneys stones and they have been shown to be safe and effective in the treatment of stones similar in size and location to your own.

Two procedure types will be investigated:

  1. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) vacuum-assisted tube with suction capability to assess the kidney and extract the stone.
  2. Miniaturized percutaneous nephrolithotomy performed using a 16 Fr (6 mm diameter) standard tube to assess the kidney and extract the stone.

Approximately 90 people will take part in this study at Cleveland Clinic. The duration of the study will include the day of the surgery and following hospital stay until postoperative follow-up appointment with the surgeon approximately 4-6 weeks after the procedure.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Actual Study Start Date : August 29, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: vacuum-assisted sheath Device: vacuum assisted sheath
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
Active Comparator: passive suction via conventional sheath Device: passive suction via conventional sheath
conventional access sheath for stone retrieval using current technique via passive suction


Outcome Measures
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Primary Outcome Measures :
  1. Aim 1: Stone free rate [ Time Frame: 6 weeks ]
    The primary outcome of SFR will be measured using conventional follow up of post-operative NCCT at 6 weeks. NCCT provides the most definitive assessment for post-operative stone burden and allows assessment of radiolucent stones when compared to ultrasound or abdominal x-ray

  2. Aim 2: Intraoperative variables [ Time Frame: 3-7 days ]
    Patients with positive cultures will be treated with appropriate pre-operative antibiotics between 3 to 7 days depending on symptoms. Antibiotics on day of surgery will be selected according to their last pre-operative urine culture which is our standard of care for patients undergoing PCNL

  3. Aim 3: Post-operative Outcomes and Complications [ Time Frame: 1 day ]
    Post-operative pain scores will be evaluated using a visual analogue scale (VAS) in the post-anesthesia care unit (PACU) and on postoperative day 1. The questionnaire may be filled out on a paper survey or an electronic REDCap survey sent via email. An electronic VAS has shown to be reliable and interchangeable with a paper VAS


Eligibility Criteria
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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 with planned prone mini-PCNL and a preoperative NCCT
  • Primary stone size: 10-25 mm
  • Pre-existing indwelling nephrostomy tube or ureteral stent permitted
  • Age: ≥ 18 years old
  • Gender: all
  • Ethnicity: all
  • Capable of giving informed consent
  • Capable and willing to fulfill requirements of the study

Exclusion Criteria:

  • Anticoagulated or history of coagulopathy
  • Congenital renal anomalies
  • Prior ipsilateral upper urinary tract reconstructive procedures
  • Conversion to open procedure
  • Multiple access tracts
  • Inability to give informed consent or unable to meet requirements of the study for any reason
Contacts and Locations
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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): NCT05993546


Contacts
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Contact: Marina Markovic 216-444-1152 MARKOVM@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Marina Markovic    216-444-1152    MARKOVM@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Sriharan Sivalingam Principal Investigator
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT05993546    
Other Study ID Numbers: 23-104
First Posted: August 15, 2023    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Urolithiasis
Urinary Calculi
Male Urogenital Diseases
Calculi
Pathological Conditions, Anatomical