Pleural EffusionNCT02036398
Tubeless Versus Standard Upper Pole Percutaneous Nephrolithotomy
A study testing Double J stent without nephrostomy and nephrostomy tube and double J stent in people with Pleural Effusion, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL) with nephrostomy placement and double J stent and PCNL with double J placement only without nephrostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Double J stent without nephrostomy and nephrostomy tube and double J stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to 7 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing upper pole percutaneous nephrolithotomy older than 18 years of age and willing to participate
Who cannot join
- Patients younger than 18 years of age
- Patients unwilling to participate in the study
- Patients that nephrostomy tube placement was a prerequisite at the end of the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Complications Between Patients Undergoing Standard Percutaneous Nephrolithotomy With Nephrostomy Tube Placement and Tubeless Percutaneous Nephrolithotomy With Double J Stent Only Placement
Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL) with nephrostomy placement and double J stent and PCNL with double J placement only without nephrostomy.
Read the detailed description
Measurement of complications in and comparison between two groups of patients undergoing upper pole PCNL. First group consists of patients left with nephrostomy and double J stent and the second group includes patients left with double J stent only without nephrostomy.
- Conditions
- Pleural Effusion
- Being tested
- Double J stent without nephrostomy, nephrostomy tube and double J stent
- Keywords
- Percutaneous Nephrolithotomy (PCNL), Nephrostomy, Double J stent, PleuraL Effusion
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double J stent without nephrostomyDevice
Double J stent only left at the end of the procedure without placement of a nephrostomy tube
nephrostomy tube and double J stentDevice
Double J stent and nephrostomy tube left at end of procedure
| Study group | Role | What they receive |
|---|---|---|
| Nephrostomy tube + double J stent | Active comparator | Standard therapy group with nephrostomy tube and double J stent left at the end of the PCNL Receives: Device: Double J stent without nephrostomy; Device: nephrostomy tube and double J stent |
| Double J stent without nephrostomy | Experimental | Double J stent only left at the end of the procedure Receives: Device: Double J stent without nephrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with pleural effusion
Assessment and comparison of pleural effusion incidence between patients in both groups
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2013
- Primary completion7 Apr 2017
- Study completion7 Apr 2017
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 Pleural EffusionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Goldberg, Rabin Medical Center
- Investigators
- Hanan Goldberg, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036398
- Sponsor's protocol ID
- RMC-6405
- Status last verified
- Nov 2018
- First submitted
- 10 Jan 2014
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldberg H, Nevo A, Shtabholtz Y, Lubin M, Baniel J, Margel D, Ehrlich Y, Lifshitz D. Tubeless supra-costal percutaneous nephrolithotomy is associated with significantly less hydrothorax: a prospective randomized clinical study. BJU Int. 2020 Feb;125(2):276-283. doi: 10.1111/bju.14950. Epub 2019 Dec 3.
PubMed 31721407
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Complications Between Patients Undergoing Standard Percutaneous Nephrolithotomy With Nephrostomy Tube Placement and Tubeless Percutaneous Nephrolithotomy With Double J Stent Only Placement
- ClinicalTrials.gov ID
- NCT02036398
- Acronym / sponsor ID
- RMC-6405
- Conditions
- Pleural Effusion
- Keywords
- Percutaneous Nephrolithotomy (PCNL), Nephrostomy, Double J stent, PleuraL Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 7 Apr 2017 (actual)
- Study completion
- 7 Apr 2017 (actual)
- First posted
- 15 Jan 2014 (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.
Comparison of complications between standard upper pole percutaneous nephrolithotomy (PCNL) with nephrostomy placement and double J stent and PCNL with double J placement only without nephrostomy.
Detailed description
Measurement of complications in and comparison between two groups of patients undergoing upper pole PCNL. First group consists of patients left with nephrostomy and double J stent and the second group includes patients left with double J stent only without nephrostomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nephrostomy tube + double J stent | Active comparator | Device: Double J stent without nephrostomy, Device: nephrostomy tube and double J stentStandard therapy group with nephrostomy tube and double J stent left at the end of the PCNL |
| Double J stent without nephrostomy | Experimental | Device: Double J stent without nephrostomyDouble J stent only left at the end of the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing upper pole percutaneous nephrolithotomy older than 18 years of age and willing to participate
Key exclusion criteria (3 listed)
- Patients younger than 18 years of age
- Patients unwilling to participate in the study
- Patients that nephrostomy tube placement was a prerequisite at the end of the procedure
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 |
|---|---|---|
| Double J stent without nephrostomyDouble J stent only left at the end of the procedure without placement of a nephrostomy tube | Device | Double J stent without nephrostomy, Nephrostomy tube + double J stent |
| nephrostomy tube and double J stentDouble J stent and nephrostomy tube left at end of procedure | Device | Nephrostomy tube + double J stent |
Primary outcome
Number of Participants with pleural effusion
Time frame: 30 days
Assessment and comparison of pleural effusion incidence between patients in both groups
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 28 Nov 2018.
- Derived from this study: PubMed 31721407Goldberg H, Nevo A, Shtabholtz Y, Lubin M, Baniel J, Margel D, Ehrlich Y, Lifshitz D. Tubeless supra-costal percutaneous nephrolithotomy is associated with significantly less hydrothorax: a prospective randomized clinical study. BJU Int. 2020 Feb;125(2):276-283. doi: 10.1111/bju.14950. Epub 2019 Dec 3.
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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.
Hanan Goldberg, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double J stent without nephrostomy and nephrostomy tube and double J stent in people with Pleural Effusion, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 3 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 28 Nov 2018. 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 Israel. 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?
Number of Participants with pleural effusion (time frame: 30 days). 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 NCT02036398, 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 28 Nov 2018.