Clinical trial NCT04069013: Standard vs Mini-PCNL for the Treatment of Stone Disease
Official title: Randomized Controlled Trial Comparing Surgical Outcomes Following PCNL and Mini PCNL in the Treatment of Kidney Stones
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urolithiasis
Kidney Stone
Kidney Calculi
Ureteral Calculi
Kidney Diseases
Keywords: Percutaneous Nephrolithotomy
PCNL
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Massachusetts General Hospital
name: Vanderbilt University Medical Center
name: Duke University
name: Ohio State University
name: Columbia University
name: Dartmouth-Hitchcock Medical Center
First posted: 2019-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss
timeFrame: Post-operative day 1
Secondary outcomes:
measure: Surgical outcomes
timeFrame: 30 Days
measure: Complication Rates
timeFrame: 30 Days
measure: Renal Pelvis Pressures
timeFrame: Intraoperative
measure: Procalcitonin- Inflammatory Markers
timeFrame: Post operative day 1
measure: IL-6 Inflammatory Markers
timeFrame: Post operative day 1
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Manoj Monga, MD
role: PRINCIPAL_INVESTIGATOR
References: