Standard vs Mini-PCNL for the Treatment of Stone Disease

Not Applicable

Recruiting

• Conditions: Kidney Stone; Kidney Calculi; Kidney Diseases; Ureteral Calculi; Urolithiasis
• Interventions: Procedure: PCNL

• Registration Number: NCT04069013
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-23
• Study First Posted: 2019-08-28
• Study Start: 2022-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard PCNL	PCNL	Patients receive a standard PCNL procedure using a 24 fr tract
Mini-PCNL	PCNL	Patients receive a mini-PCNL procedure using a 16 fr tract

Primary Outcome Measures

Name	Time	Method
Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss	Post-operative day 1	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

Name	Time	Method
Procalcitonin- Inflammatory Markers	Post operative day 1	Procalcitonin
Surgical outcomes	30 Days	Discharge time
Complication Rates	30 Days	Complication Rates
IL-6 Inflammatory Markers	Post operative day 1	IL-6
Renal Pelvis Pressures	Intraoperative	Intraoperative renal pelvis pressures

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States