Comparing Previously Placed Nephrostomy Tract (NT) Versus Single Stage Percutaneous Nephrolithotomy (PCNL)

A Prospective, Randomized Trial Comparing Previously Placed Nephrostomy Tract and Single Stage Percutaneous Nephrolithotomy and Its Effects on Infection and Bleeding Related Complications

The investigators are trying to determine whether placement of a nephrostomy tube prior to definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce complications related to bleeding and infection compare to obtaining renal access at the time of surgery.

Study Overview

• Status: Terminated
• Conditions: Urolithiasis
• Intervention / Treatment: Procedure: NT 1 day before PCNL

Detailed Description

We seek to identify whether the placement of a nephrostomy tract prior to surgery versus at the time of PCNL will: 1. decrease blood loss and related complications, and 2. decrease infection-related complications by providing the ability to an accurate collection of urine for culture and initiating appropriate antibiotic treatment prior to definitive stone management. In addition, we seek to determine whether renal puncture under fluoroscopic vs ultrasonic guidance is associated with less blood loss. Although retrospective studies have shown some benefit to placing the nephrostomy tube prior to surgery in terms of decreased blood loss, there are no well-designed, prospective studies comparing the two treatment approaches. We seek to determine which treatment approach is safer, more efficacious, and more cost-effective through a prospective, randomized trial.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients age 18 years to 90 years old,
• Patients with stone disease
• Patients who hoose to have PCNL for treatment
• Patients who understand the informed consent

Exclusion Criteria:

• Minors
• Unable to understand the informed consent
• Unwilling to fill out the SF 36 questionnaire

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NT prior to PCNL; A bladder urine culture will be obtained prior to nephrostomy tube placement and antibiotic treatment will be initiated if necessary. A nephrostomy tube will be placed at least one week prior to surgery in the Vascular Interventional Radiology (VIR) suite under fluoroscopic or ultrasound guidance. The type of imaging will be determined by the radiologist at the time of procedure and documented. A renal pelvis urine culture will be obtained at the time of nephrostomy tube placement. If the culture is positive, the patients will be treated with appropriate antibiotics for at least one week prior to PCNL. If the culture is negative, the patient will be stratified into 2 groups: Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated.; If neither of the above criteria (a.) are met, and the urine culture is negative, no antibiotics will be administered except peri-operatively according to standard protocol.	Procedure: NT 1 day before PCNL; A bladder urine culture will be obtained prior to nephrostomy tube placement and antibiotic treatment will be initiated if necessary. A nephrostomy tube will be placed at least one day prior to surgery in the Vascular Interventional Radiology (VIR) suite under fluoroscopic or ultrasound guidance. The type of imaging will be determined by the radiologist at the time of procedure and documented. A renal pelvis urine culture will be obtained at the time of nephrostomy tube placement. If the culture is positive, the patients will be treated with appropriate antibiotics for at least one week prior to PCNL. If the culture is negative, the patient will be stratified into 2 groups: Hydronephrosis present and/or stone greater than 2cm empiric antibiotics will be initiated.; If neither of the above criteria (a.) are met, and the urine culture is negative, no antibiotics will be administered except peri-operatively according to standard protocol.
No Intervention: NT at the surgery; A bladder urine culture will be obtained prior to surgery and appropriate antibiotic treatment will be initiated if necessary. The nephrostomy tract will be placed at the time of surgery under fluoroscopic guidance. All patients will receive empiric intravenous peri-operative antibiotics at induction. Renal pelvis urine and stone will be collected for culture and post-operative treatment will be initiated if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of complications related to bleeding and infection	We aim to determine whether placement of a nephrostomy tube prior to definitive stone surgery and under ultrasonic or fluoroscopic guidance will reduce complications related to bleeding and infection compared to obtaining renal access at the time of surgery.	3 years

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 22, 2009
• First Posted (Estimate): May 25, 2009

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Renal stones
• Additional Relevant MeSH Terms: Urologic Diseases; Urolithiasis
• Other Study ID Numbers: Alana Desai PCNL Study-09-0709