Renal StoneNCT03189264
Percutaneous Nephrolithotomy for Treatment of Kidney Stones Greater Than 2 cm
A study testing percutaneous nephrolithotomy for kidney stones in people with Renal Stone, run by Dr Carlos Hernández at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Stone
- What is being tested?
- percutaneous nephrolithotomy for kidney stones
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteColombia
- Study dates
- 10 May 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
- Non-staghorn kidney stones greater than 2 cm
Who cannot join
- Coagulopathies
- Solitary Functioning Kidney
- Pyonephrosis
- Pregnancy
- Urinary tract infection
- Cardiopulmonary Restrictions Limiting Prone Position
Show all 9Show fewer
- BMI greater than 35
- More of 2 puncture of the excretory tract
- STONE score equal or greater than 12
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Renal Stone
- Being tested
- percutaneous nephrolithotomy for kidney stones
- Keywords
- Percutaneous Nephrolithotomy, Postoperative Complications, Renal Stone, Surgical Success, Surgical Complications, Pneumatic Dilation
- Medical subject headings
- Nephrolithiasis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrolithotomy for kidney stonesProcedure or surgery
Also called Percutaneous nephrolithotomy with Coaxial Dilatation, Percutaneous nephrolithotomy with Pneumatic Balloon
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.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous nephrolithotomy with Coaxial Dilatation | Active comparator | Percutaneous nephrolithotomy with Coaxial Dilatation for treatment of kidney stones greater than 2 cm. Receives: 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. Receives: Procedure: percutaneous nephrolithotomy for kidney stones |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start10 May 2017
- Primary completion31 Aug 2017 (estimated)
- Study completion30 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Renal StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Carlos Hernández
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Carlos Hernández, Los Comuneros Hospital Universitario Bucaramanga
- Investigators
- Carlos E Hernandez, MD, Principal investigator, HOSPITAL UNIVERSITARIO LOS COMUNEROSAndres Gutierrez, MD, Study chair, HOSPITAL UNIVERSITARIO LOS COMUNEROSJose G Ramos, MD, Study chair, HOSPITAL UNIVERSITARIO LOS COMUNEROSDiana M Chaparro, MD, Study chair, HOSPITAL UNIVERSITARIO LOS COMUNEROSEduardo Ardila, MD, Study chair, HOSPITAL UNIVERSITARIO LOS COMUNEROS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189264
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2017
- First submitted
- 8 May 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21388242GOODWIN 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.
PubMed 13233046Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
PubMed 1006190Beiko 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.
PubMed 25221917Tailly 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.
PubMed 26225169Thomas 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.
PubMed 21333334Akhavein 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.
PubMed 25530366Okhunov 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.
PubMed 23540858Shahrour W, Andonian S. Ambulatory percutaneous nephrolithotomy: initial series. Urology. 2010 Dec;76(6):1288-92. doi: 10.1016/j.urology.2010.08.001.
PubMed 21130245Beiko 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.
PubMed 20694090
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Nephrolithotomy With Coaxial Dilatation vs Pneumatic Balloon for Treatment of Kidney Stones Greater Than 2 cm
- ClinicalTrials.gov ID
- NCT03189264
- Acronym / sponsor ID
- 1
- Conditions
- Renal Stone
- Keywords
- Percutaneous Nephrolithotomy, Postoperative Complications, Renal Stone, Surgical Success, Surgical Complications, Pneumatic Dilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dr Carlos HernándezUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 30 Sep 2017 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous nephrolithotomy with Coaxial Dilatation | Active comparator | Procedure: percutaneous nephrolithotomy for kidney stonesPercutaneous nephrolithotomy with Coaxial Dilatation for treatment of kidney stones greater than 2 cm. |
| Percutaneous nephrolithotomy with Pneumatic Balloon | Placebo comparator | Procedure: percutaneous nephrolithotomy for kidney stonesPercutaneous nephrolithotomy with Pneumatic Balloon for treatment of kidney stones greater than 2 cm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient over 18 years old
- Non-staghorn kidney stones greater than 2 cm
Key exclusion criteria (9 listed)
- Coagulopathies
- Solitary Functioning Kidney
- Pyonephrosis
- Pregnancy
- Urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous nephrolithotomy for kidney stonesAlso: Percutaneous nephrolithotomy with Coaxial Dilatation, Percutaneous nephrolithotomy with Pneumatic BalloonUse 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. | Procedure or surgery | Percutaneous nephrolithotomy with Coaxial Dilatation, Percutaneous nephrolithotomy with Pneumatic Balloon |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 21388242Lopes 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.
- Results publication: PubMed 13233046GOODWIN 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.
- Results publication: PubMed 1006190Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.
- Results publication: PubMed 25221917Beiko 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.
- Results publication: PubMed 26225169Tailly 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.
- Results publication: PubMed 21333334Thomas 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.
- Results publication: PubMed 25530366Akhavein 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.
- Results publication: PubMed 23540858Okhunov 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.
- Results publication: PubMed 21130245Shahrour W, Andonian S. Ambulatory percutaneous nephrolithotomy: initial series. Urology. 2010 Dec;76(6):1288-92. doi: 10.1016/j.urology.2010.08.001.
- Results publication: PubMed 20694090Beiko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos E Hernandez, MD principal investigator
HOSPITAL UNIVERSITARIO LOS COMUNEROS
Andres Gutierrez, MD study chair
HOSPITAL UNIVERSITARIO LOS COMUNEROS
Jose G Ramos, MD study chair
HOSPITAL UNIVERSITARIO LOS COMUNEROS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous nephrolithotomy for kidney stones in people with Renal Stone, run by Dr Carlos Hernández at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of intraoperative and postoperative complications that occur with the use of pneumatic dilation and with traditional coaxial dilatation. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189264, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.