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

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05993546
• Other study ID #: 23-104
• Status: Recruiting
• Phase: N/A
• Start date: August 29, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: Marina Markovic
• Phone: 216-444-1152
• Email: MARKOVM[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis

Intervention

Device:
• vacuum assisted sheath
allows for simultaneous suction with continuous irrigation throughout the case to enhance visibility and facilitate stone retrieval
• passive suction via conventional sheath
conventional access sheath for stone retrieval using current technique via passive suction

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aim 1: Stone free rate	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	6 weeks
Primary	Aim 2: Intraoperative variables	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	3-7 days
Primary	Aim 3: Post-operative Outcomes and Complications	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	1 day