Percutaneous Nephrolithotomy for Treatment of Kidney Stones Greater Than 2 cm

NCT03189264 | Unknown DMC FDA Device

• 1 other identifier: 1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Stone

Keywords

Percutaneous Nephrolithotomy; Postoperative Complications; Renal Stone; Surgical Success; Surgical Complications; Pneumatic Dilation

Outcome Measures

Primary Outcomes (1)

• Rate of intraoperative and postoperative complications that occur with the use of pneumatic dilation and with traditional coaxial dilatation.

  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

Study Arms (2)

Percutaneous nephrolithotomy with Coaxial Dilatation

ACTIVE COMPARATOR

Percutaneous nephrolithotomy with Coaxial Dilatation for treatment of kidney stones greater than 2 cm.

Procedure: percutaneous nephrolithotomy for kidney stones

Percutaneous nephrolithotomy with Pneumatic Balloon

PLACEBO COMPARATOR

Percutaneous nephrolithotomy with Pneumatic Balloon for treatment of kidney stones greater than 2 cm.

Procedure: percutaneous nephrolithotomy for kidney stones

Interventions

percutaneous nephrolithotomy for kidney stones PROCEDURE

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.

Also known as: Percutaneous nephrolithotomy with Coaxial Dilatation, Percutaneous nephrolithotomy with Pneumatic Balloon

Percutaneous nephrolithotomy with Coaxial Dilatation; Percutaneous nephrolithotomy with Pneumatic Balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Carlos Hernández: lead

Study Sites (1)

Hospital Universitario Los Comuneros

Bucaramanga, Colombia

Location

Related Publications (10)

• Lopes T, Sangam K, Alken P, Barroilhet BS, Saussine C, Shi L, de la Rosette J; Clinical Research Office of The Endourological Society Percutaneous Nephrolithotomy Study Group. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: tract dilation comparisons in 5537 patients. J Endourol. 2011 May;25(5):755-62. doi: 10.1089/end.2010.0488. Epub 2011 Mar 9.

  PMID: 21388242 BACKGROUND

• GOODWIN WE, CASEY WC, WOOLF W. Percutaneous trocar (needle) nephrostomy in hydronephrosis. J Am Med Assoc. 1955 Mar 12;157(11):891-4. doi: 10.1001/jama.1955.02950280015005. No abstract available.

  PMID: 13233046 RESULT

• Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.

  PMID: 1006190 RESULT

• Beiko D, Elkoushy MA, Kokorovic A, Roberts G, Robb S, Andonian S. Ambulatory percutaneous nephrolithotomy: what is the rate of readmission? J Endourol. 2015 Apr;29(4):410-4. doi: 10.1089/end.2014.0584. Epub 2014 Oct 23.

  PMID: 25221917 RESULT

• Tailly T, Razvi H. The S.T.O.N.E. nephrolithometry scoring system: How valid is it? Can Urol Assoc J. 2015 May-Jun;9(5-6):196. doi: 10.5489/cuaj.3020. No abstract available.

  PMID: 26225169 RESULT

• Thomas K, Smith NC, Hegarty N, Glass JM. The Guy's stone score--grading the complexity of percutaneous nephrolithotomy procedures. Urology. 2011 Aug;78(2):277-81. doi: 10.1016/j.urology.2010.12.026. Epub 2011 Feb 17.

  PMID: 21333334 RESULT

• Akhavein A, Henriksen C, Syed J, Bird VG. Prediction of single procedure success rate using S.T.O.N.E. nephrolithometry surgical classification system with strict criteria for surgical outcome. Urology. 2015 Jan;85(1):69-73. doi: 10.1016/j.urology.2014.09.010.

  PMID: 25530366 RESULT

• Okhunov Z, Friedlander JI, George AK, Duty BD, Moreira DM, Srinivasan AK, Hillelsohn J, Smith AD, Okeke Z. S.T.O.N.E. nephrolithometry: novel surgical classification system for kidney calculi. Urology. 2013 Jun;81(6):1154-9. doi: 10.1016/j.urology.2012.10.083. Epub 2013 Mar 26.

  PMID: 23540858 RESULT

• Shahrour W, Andonian S. Ambulatory percutaneous nephrolithotomy: initial series. Urology. 2010 Dec;76(6):1288-92. doi: 10.1016/j.urology.2010.08.001.

  PMID: 21130245 RESULT

• Beiko D, Lee L. Outpatient tubeless percutaneous nephrolithotomy: the initial case series. Can Urol Assoc J. 2010 Aug;4(4):E86-90. doi: 10.5489/cuaj.886.

  PMID: 20694090 RESULT

MeSH Terms

Conditions

Nephrolithiasis; Postoperative Complications

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Carlos E Hernandez, MD

  HOSPITAL UNIVERSITARIO LOS COMUNEROS

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: June 16, 2017
• Study Start: May 10, 2017
• Primary Completion: August 31, 2017
• Study Completion: September 30, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)