Standard vs Mini-PCNL for the Treatment of Stone Disease

NeuroTherapia, Inc.

Status: Enrolling

Conditions: Kidney Diseases; Kidney Stone; Urolithiasis; Ureteral Calculi; Kidney Calculi

Treatments: Procedure: PCNL

Study type: Interventional

Funder types: Other

Identifiers

NCT04069013

19-589

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Standard PCNL

Active Comparator group

Description:

Patients receive a standard PCNL procedure using a 24 fr tract

Treatment:

Procedure: PCNL

Mini-PCNL

Active Comparator group

Description:

Patients receive a mini-PCNL procedure using a 16 fr tract

Treatment:

Procedure: PCNL