Kidney StonesNCT00873054
Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
An observational study of Kidney Stones, run by CAMC Health System at 1 site in United States.
Trial summary
The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jan 2011
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community patients who present to Charleston Area Medical Center (CAMC) or the private urology clinics of Drs. Tierney, Martinez or Davalos with kidney stones between 10 and 20 mm in size would be screened based on inclusion criteria for possible enrollment in the study.
Who may be able to join
- Patients of both sex with age greater than 18 years to 90 years
- Stone burden between 10 and 20 mm diagnosed by CT scan
- Patient must be agreeable to randomization between shock wave lithotripsy and percutaneous stone removal
Who cannot join
- Patients with bleeding diathesis or taking anti-platelet or anti-coagulant medication
- Patients who are pregnant based on routine pre-operative pregnancy testing
- Patients with skin to stone size greater than 12 cm (measured routinely on CT scan)
- Patients with either Horseshoe kidney, transplant kidney or a solitary kidney
- Patients with ureteral calculi
- Patients with stone size of < 10 mm and > 20 mm
- Ureteropelvic junction obstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
Urology Center of Charleston
Charleston, West Virginia, 25301
About this study
The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence.
Read the detailed description
Extracorporeal shock wave lithotripsy is preferred for small stones less than 10 mm in size. Percutaneous nephrolithotomy is the standard therapy used for large kidney stones greater than 20 millimeters or stones in the lower kidney. For moderate sized kidney stone (10-20 mm),currently the options for treatment include both methods. However, no studies have proven that one procedure is better than the other. So, we will compare both the procedures for breaking the kidney stone. Our main outcome measures will be the stone-free status after the procedure. Other outcome measures are assessment of morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment. Patient will be assessed for infection at post-operative office visits to include a basic urinalysis only if they have systemic indicators of infection (fever, dysuria, frequency, etc.). Pain will be monitored with the scale of 0-10 points. Also we will review of stone density on Computerized Tomography (CT) scans and the effect this has on success of both procedures. We hope with PCNL stone-free rates will be minimum with minimal morbidity and ultimately improve patient care.
- Conditions
- Kidney Stones
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 ESWL | In this procedure,scope will be placed inside bladder and a plastic tube (stent) will be left to drain the kidney on the affected side in a routine manner. Next the patient will be transferred to a separate room and sound waves will be aimed at the center of the stone until the stone is broken into pieces. | |
| 2 PCNL | In this procedure,scope will be placed inside bladder and a plastic tube (stent) will be left to drain the kidney on the affected side in a routine manner. Next, a small (1cm) cut will be made in the back and a tube will be placed into the kidney. Through this tube a small camera will be placed inside the kidney and break the stone into many pieces and remove them through the same tube. All fragments that can be seen will be removed. A different plastic tube (drain) will be placed through the cut and into the kidney and left in place for 5-7 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size.
Measured: Within 3 months of enrollment
Secondary outcomes (1)
A secondary objective is to assess the morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment.
Measured: Within 3 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionOct 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StonesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Deem, DO, CAMC Health System
- Investigators
- Julio G. Davalos, MD, Principal investigator, CAMC Medical Staff - with admitting privilegesFrederick Martinez, M.D., Principal investigator, CAMC Medical Staff - with admitting privileges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873054
- Sponsor's protocol ID
- 08-08-2078
- Status last verified
- Jan 2014
- First submitted
- 31 Mar 2009
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Setthawong V, Srisubat A, Potisat S, Lojanapiwat B, Pattanittum P. Extracorporeal shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or retrograde intrarenal surgery (RIRS) for kidney stones. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007044. doi: 10.1002/14651858.CD007044.pub4.
PubMed 37526261
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy
- ClinicalTrials.gov ID
- NCT00873054
- Acronym / sponsor ID
- 08-08-2078
- Conditions
- Kidney Stones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Apr 2009 (estimated)
- 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.
The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence.
Detailed description
Extracorporeal shock wave lithotripsy is preferred for small stones less than 10 mm in size. Percutaneous nephrolithotomy is the standard therapy used for large kidney stones greater than 20 millimeters or stones in the lower kidney. For moderate sized kidney stone (10-20 mm),currently the options for treatment include both methods. However, no studies have proven that one procedure is better than the other. So, we will compare both the procedures for breaking the kidney stone. Our main outcome measures will be the stone-free status after the procedure. Other outcome measures are assessment of morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment. Patient will be assessed for infection at post-operative office visits to include a basic urinalysis only if they have systemic indicators of infection (fever, dysuria, frequency, etc.). Pain will be monitored with the scale of 0-10 points. Also we will review of stone density on Computerized Tomography (CT) scans and the effect this has on success of both procedures. We hope with PCNL stone-free rates will be minimum with minimal morbidity and ultimately improve patient care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 ESWL | – | –In this procedure,scope will be placed inside bladder and a plastic tube (stent) will be left to drain the kidney on the affected side in a routine manner. Next the patient will be transferred to a separate room and sound waves will be aimed at the center of the stone until the stone is broken into pieces. |
| 2 PCNL | – | –In this procedure,scope will be placed inside bladder and a plastic tube (stent) will be left to drain the kidney on the affected side in a routine manner. Next, a small (1cm) cut will be made in the back and a tube will be placed into the kidney. Through this tube a small camera will be placed inside the kidney and break the stone into many pieces and remove them through the same tube. All fragments that can be seen will be removed. A different plastic tube (drain) will be placed through the cut and into the kidney and left in place for 5-7 days. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community patients who present to Charleston Area Medical Center (CAMC) or the private urology clinics of Drs. Tierney, Martinez or Davalos with kidney stones between 10 and 20 mm in size would be screened based on inclusion criteria for possible enrollment in the study.
Key inclusion criteria (3 listed)
- Patients of both sex with age greater than 18 years to 90 years
- Stone burden between 10 and 20 mm diagnosed by CT scan
- Patient must be agreeable to randomization between shock wave lithotripsy and percutaneous stone removal
Key exclusion criteria (7 listed)
- Patients with bleeding diathesis or taking anti-platelet or anti-coagulant medication
- Patients who are pregnant based on routine pre-operative pregnancy testing
- Patients with skin to stone size greater than 12 cm (measured routinely on CT scan)
- Patients with either Horseshoe kidney, transplant kidney or a solitary kidney
- Patients with ureteral calculi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size.
Time frame: Within 3 months of enrollment
1 secondary outcome
A secondary objective is to assess the morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment.
Time frame: Within 3 months of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
- Derived from this study: PubMed 37526261Setthawong V, Srisubat A, Potisat S, Lojanapiwat B, Pattanittum P. Extracorporeal shock wave lithotripsy (ESWL) versus percutaneous nephrolithotomy (PCNL) or retrograde intrarenal surgery (RIRS) for kidney stones. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007044. doi: 10.1002/14651858.CD007044.pub4.
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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.
Julio G. Davalos, MD principal investigator
CAMC Medical Staff - with admitting privileges
Frederick Martinez, M.D. principal investigator
CAMC Medical Staff - with admitting privileges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stones, run by CAMC Health System at 1 site in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 3 Feb 2014. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size. (time frame: Within 3 months of enrollment). 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 NCT00873054, which also lists 1 linked publication.
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 3 Feb 2014.