Percutaneous Nephrolithotomy for Treatment of Kidney Stones Greater Than 2 cm

June 14, 2017 updated by: Dr Carlos Hernández

Percutaneous Nephrolithotomy With Coaxial Dilatation vs Pneumatic Balloon for Treatment of Kidney Stones Greater Than 2 cm

Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure considered as the treatment of choice for the management of large-scale and fully-formed kidney stones.This procedure has a 5% risk of complications including bleeding, the lesion of the collecting system, the risk of urinary infection and bacteremia. New surgical tools such as dilatation of the nephrostomy tract with mechanical dilatation contribute to the reduction of these risks, together with an improvement in the operative times and a lower rate of complications.

At present there are multiple scales measuring the lithiasic morphology (Guy, the STONE nephrolitometry score system and the nomogram of the Office of Clinical Investigation of the Endourology Society - CROES) which allow to evaluate the degree of complexity of the stone, the possibility of residual stones and the risk of complications. These tools allow us to do a better analysis of the risk factors of the patient who will be taken to this type of endoscopic procedure in order to decrease morbidity and complication rates.

Hypothesis:

The use of pneumatic dilators during percutaneous nephrolithotomy reduces the rates of intraoperative and postoperative complications, which would have an impact on hospitalization times and surgical success for the management of renal stone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Nephrolithiasis is a major worldwide source of morbidity, constituting a common urological disease affecting 10-15% of the world population, with a subsequent clinical relapse rate of approximately 50%. Recent technological and surgical advances have reduced the need for open surgery with less invasive procedures, such as percutaneous nephrolithotomy (PCNL), extracorporeal shock wave lithotripsy (SWL) and retrograde ureteroscopy. The selection of the surgical procedure generally depends on the size, composition, location of the renal stone, the existence of obstruction and anatomical variations of the urinary system. Today, PCNL is the established procedure for stone greater than 2 cm; The procedure usually involves three main stages: it begins with the insertion of a ureteral catheter to perform a retrograde study with contrast medium where the anatomy of the kidney is evaluated, then the puncture is performed by inserting a surgical needle on the skin to the specific location of the stone, with subsequent dilatation of the tract to the collecting system, and once this access has been made it is proceeded to carry out the fragmentation and extraction of the stone through various types of instruments.

The success and results of the treatment of surgery are very well known and highly dependent on precision in the puncture stage (the stones must be achieved with a precise and direct path), make this step is the most challenge for surgeons. The ideal access is one that allows complete removal of the stones while minimizing intraoperative bleeding. Needle punctures and their complications, such as kidney injuries and adjacent organs, eventually impair the overall surgical success and outcome of the patient. Although PCNL is considered minimally invasive surgery (MIS) with many associated benefits, such as the production of small incisions in the patient, reducing hospitalization time and postoperative recovery, some complications still occur frequently. The dilation of the nephrostomy tract is the second step in which there are more complications, since it depends on an optimal puncture of the collecting system and a precise manual control to avoid damages of the collecting system or to increase the risks of bleeding.

Restricted vision, difficulty in handling the Instrumental, restrictive mobility within the kidney, skill levels of hand-eye coordination of the surgeon, deviation of the needle, moving anatomical objective, are a constant challenge for the surgeon. Several technological advances have been proposed to improve the effectiveness of this procedure. In regard to puncture and dilatation, relevant contributions have been provided by the improvement in medical imaging techniques, as well as the fusion of multiple imaging procedures.

Main goal

To determine the highest rate of intraoperative and early postoperative complications (bleeding, pain) with the use of the various methods of access to the renal collecting system during percutaneous nephrolithotomy for the treatment of kidney stones greater than 2 cm than 2 cm between April 2017 and January 2018.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bucaramanga, Colombia
        • Hospital Universitario Los Comuneros

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient over 18 years old
  • Non-staghorn kidney stones greater than 2 cm

Exclusion Criteria:

  • Coagulopathies
  • Solitary Functioning Kidney
  • Pyonephrosis
  • Pregnancy
  • Urinary tract infection
  • Cardiopulmonary Restrictions Limiting Prone Position
  • BMI greater than 35
  • More of 2 puncture of the excretory tract
  • STONE score equal or greater than 12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Percutaneous nephrolithotomy with Coaxial Dilatation
Percutaneous nephrolithotomy with Coaxial Dilatation for treatment of kidney stones greater than 2 cm.
Procedure: percutaneous nephrolithotomy for kidney stones
Use of various methods of access to the renal collecting system (pneumatic balloon dilatation vs. traditional technique with coaxial dilators) during percutaneous nephrolithotomy for treatment of kidney stones greater than 2 cm.
Other Names:
  • Percutaneous nephrolithotomy with Coaxial Dilatation
  • Percutaneous nephrolithotomy with Pneumatic Balloon
Placebo Comparator: Percutaneous nephrolithotomy with Pneumatic Balloon
Percutaneous nephrolithotomy with Pneumatic Balloon for treatment of kidney stones greater than 2 cm.
Procedure: percutaneous nephrolithotomy for kidney stones
Use of various methods of access to the renal collecting system (pneumatic balloon dilatation vs. traditional technique with coaxial dilators) during percutaneous nephrolithotomy for treatment of kidney stones greater than 2 cm.
Other Names:
  • Percutaneous nephrolithotomy with Coaxial Dilatation
  • Percutaneous nephrolithotomy with Pneumatic Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of intraoperative and postoperative complications that occur with the use of pneumatic dilation and with traditional coaxial dilatation.
Time Frame: 8 weeks
To determine the highest rate of intraoperative and early postoperative complications with the use of various methods of access to the renal collecting system during percutaneous nephrolithotomy for the treatment of kidney stones greater than 2 cm.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Carlos Hernández

Investigators

  • Principal Investigator: Carlos E Hernandez, MD, Hospital Universitario Los Comuneros
  • Study Chair: Andres Gutierrez, MD, Hospital Universitario Los Comuneros
  • Study Chair: Jose G Ramos, MD, Hospital Universitario Los Comuneros
  • Study Chair: Diana M Chaparro, MD, Hospital Universitario Los Comuneros
  • Study Chair: Eduardo Ardila, MD, Hospital Universitario Los Comuneros

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Anticipated)

August 31, 2017

Study Completion (Anticipated)

September 30, 2017

Study Registration Dates

First Submitted

May 8, 2017

First Submitted That Met QC Criteria

June 14, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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