Standard vs Mini-PCNL for the Treatment of Stone Disease

Kidney Diseases Clinical Trial

Official title:

Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04069013
• Other study ID #: 19-589
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: The Cleveland Clinic
• Contact: Manoj Monga, MD
• Phone: 216-445-8678
• Email: mongam[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Kidney Diseases
• Kidney Stone
• Nephrolithiasis
• Ureteral Calculi
• Ureterolithiasis
• Urolithiasis

Intervention

Procedure:
• PCNL
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (8)

Lead Sponsor	Collaborator
The Cleveland Clinic	Columbia University, Dartmouth-Hitchcock Medical Center, Duke University, Massachusetts General Hospital, Ohio State University, University of British Columbia, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative day 1
Secondary	Surgical outcomes	Discharge time	30 Days
Secondary	Complication Rates	Complication Rates	30 Days
Secondary	Renal Pelvis Pressures	Intraoperative renal pelvis pressures	Intraoperative
Secondary	Procalcitonin- Inflammatory Markers	Procalcitonin	Post operative day 1
Secondary	IL-6 Inflammatory Markers	IL-6	Post operative day 1