NephrolithotomyPhase 3NCT01548196
Standard Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL
A Phase 3 study testing Standard Percutaneous nephrolithotomy in people with Nephrolithotomy, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithotomy
- What is being tested?
- Standard Percutaneous nephrolithotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Sep 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Planned single tract percutaneous nephrolithotomy
- General anesthesia for percutaneous nephrolithotomy
Who cannot join
- Age<18 years old
- Known residual calculi at the end of the procedure
- Significant hemorrhage during procedure
- Bleeding disorder (This does not include patients taking anti-coagulants as these are stopped prior to surgery.)
- Prisoners
- Inability to give informed consent
Show all 13Show fewer
- Pregnant females
- Solitary kidney
- Transplant kidney
- Pleural effusion during procedure requiring drainage
- Perforation of renal collecting system during procedure
- Incomplete stone clearance
- Chronic pain syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL
The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or ureteral stent/catheter. Primary Outcome Measures will include length of procedure and estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores, time to ambulation, time to oral intake, and pain scores will also be recorded. Time to nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge from the hospital will also be recorded. Incidence and type of post-operative complications will also be recorded.
- Conditions
- Nephrolithotomy
- Being tested
- Standard Percutaneous nephrolithotomy
- Keywords
- nephrolithotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Percutaneous nephrolithotomyProcedure or surgery
Percutaneous nephrolithotomy
| Study group | Role | What they receive |
|---|---|---|
| standard percutaneous nephrostomy | Other | Standard PCN Receives: Procedure: Standard Percutaneous nephrolithotomy |
| double-J ureteral stent, | Other | double-J ureteral stent, Receives: Procedure: Standard Percutaneous nephrolithotomy |
| open-ended ureteral catheter | Other | open-ended ureteral catheter Receives: Procedure: Standard Percutaneous nephrolithotomy |
| no nephrostomy or ureteral stent/catheter. | No intervention | no nephrostomy or ureteral stent/catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
measuring days of hospital stay after procedure, and the effect that the location of the puncture has on the length of hospital stay
Measured: until hospital discharge, about 2-3 days
Change in CBC and Chemistry Panel
Loss of blood
Measured: at time of hospital discharge, about 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Preminger, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548196
- Sponsor's protocol ID
- Pro00004138
- Status last verified
- Mar 2012
- First submitted
- 18 Oct 2011
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL
- ClinicalTrials.gov ID
- NCT01548196
- Acronym / sponsor ID
- Pro00004138
- Conditions
- Nephrolithotomy
- Keywords
- nephrolithotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Mar 2012 (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 purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or ureteral stent/catheter. Primary Outcome Measures will include length of procedure and estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores, time to ambulation, time to oral intake, and pain scores will also be recorded. Time to nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge from the hospital will also be recorded. Incidence and type of post-operative complications will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| standard percutaneous nephrostomy | Other | Procedure: Standard Percutaneous nephrolithotomyStandard PCN |
| double-J ureteral stent, | Other | Procedure: Standard Percutaneous nephrolithotomydouble-J ureteral stent, |
| open-ended ureteral catheter | Other | Procedure: Standard Percutaneous nephrolithotomyopen-ended ureteral catheter |
| no nephrostomy or ureteral stent/catheter. | No intervention | –no nephrostomy or ureteral stent/catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old
- Planned single tract percutaneous nephrolithotomy
- General anesthesia for percutaneous nephrolithotomy
Key exclusion criteria (13 listed)
- Age<18 years old
- Known residual calculi at the end of the procedure
- Significant hemorrhage during procedure
- Bleeding disorder (This does not include patients taking anti-coagulants as these are stopped prior to surgery.)
- Prisoners
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 |
|---|---|---|
| Standard Percutaneous nephrolithotomyPercutaneous nephrolithotomy | Procedure or surgery | double-J ureteral stent,, open-ended ureteral catheter, standard percutaneous nephrostomy |
Primary outcome
Length of hospital stay
Time frame: until hospital discharge, about 2-3 days
measuring days of hospital stay after procedure, and the effect that the location of the puncture has on the length of hospital stay
Change in CBC and Chemistry Panel
Time frame: at time of hospital discharge, about 2-3 days
Loss of blood
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 17 Mar 2015.
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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.
Glenn Preminger, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Percutaneous nephrolithotomy in people with Nephrolithotomy, run by Duke University 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 13 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 17 Mar 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Length of hospital stay (time frame: until hospital discharge, about 2-3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.