Image-guided BiopsyNCT02758535
Renal Parenchymal Core Needle Biopsy
A study testing coaxial renal biopsy and noncoaxial renal biopsy in people with Image-guided Biopsy and Complications, run by Modarres Hospital at 1 site in Iran.
Trial summary
Percutaneous image-guided parenchymal renal biopsy has been used to detect the different pathologies of renal parenchyma, to define the degree of reversible changes, and to define when the medical treatment fails. Read more about this study
- Who is it for?
- Ages 10 to 90 years, men only
- Conditions the study is for
- Image-guided Biopsy, Complications, Kidney Glomerulus
- What is being tested?
- coaxial renal biopsy and noncoaxial renal biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteIran
- Study dates
- Mar 2015to Mar 2016
- 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 10 to 90 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- impaired renal function
- proteinuria
- hematuria
Who cannot join
- renal hydronephrosis
- chronic renal failure
- a history of renal cell carcinoma
- suspicious renal mass
- uncorrectable coagulopathy
Trial locations and contacts
1 site in 1 country.
Iran1 site
Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences
Rasht, Gilan Province
About this study
Percutaneous image-guided parenchymal renal biopsy has been used to detect the different pathologies of renal parenchyma, to define the degree of reversible changes, and to define when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle renal biopsy is usually based on tissue sampling under guidance of either sonography or computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial technique. In coaxial technique, the introducing needle is placed in the renal parenchyma; then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although there are some reports regarding the comparison of coaxial and noncoaxial methods of renal mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been described in the literature. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in percutaneous renal parenchymal biopsy.
- Conditions
- Image-guided Biopsy, Complications, Kidney Glomerulus
- Being tested
- coaxial renal biopsy, noncoaxial renal biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coaxial renal biopsyDevice
Also called 18-gauge semiautomatic biopsy system with the coaxial needle; Tasuku Laboratory, Tochigi, Japan
In this method, a larger introducing needle is used for the puncture. The introducing needle is advanced just to the outer cortex of the kidney, and the needle angle is adjusted so that the needle pathway became mostly in the renal cortex, then the biopsy needle is inserted throughout the introducing needle and at least 4 cores are obtained. In this technique, the skin surface is punctured only once during the procedure.
noncoaxial renal biopsyDevice
Also called 18-gauge semiautomatic biopsy system without coaxial needle; Tasuku Laboratory, Tochigi, Japan
In this method, introducing needle is not used. Biopsy needle punctures the skin surface and the needle is advanced to about 10-15 mm into the renal cortex, and tissue sampling is done. After each sampling, the needle is removed and then for the next biopsy, the whole procedure is repeated until four cores being taken.
| Study group | Role | What they receive |
|---|---|---|
| Core needle biopsy with coaxial method | Experimental | The patients undergo renal biopsy with a coaxial Tru-Cut needle Receives: Device: coaxial renal biopsy |
| Core needle biopsy with noncoaxial method | Experimental | The patients undergo renal biopsy with a noncoaxial Tru-Cut needle Receives: Device: noncoaxial renal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication ratio
Measured: within 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image-guided BiopsyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Modarres Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758535
- Sponsor's protocol ID
- Renal Parenchymal Biopsy
- Status last verified
- Apr 2016
- First submitted
- 29 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Parenchymal Core Needle Biopsy
- ClinicalTrials.gov ID
- NCT02758535
- Acronym / sponsor ID
- Renal Parenchymal Biopsy
- Conditions
- Image-guided Biopsy, Complications, Kidney Glomerulus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Modarres HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 May 2016 (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.
Percutaneous image-guided parenchymal renal biopsy has been used to detect the different pathologies of renal parenchyma, to define the degree of reversible changes, and to define when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle renal biopsy is usually based on tissue sampling under guidance of either sonography or computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial technique. In coaxial technique, the introducing needle is placed in the renal parenchyma; then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although there are some reports regarding the comparison of coaxial and noncoaxial methods of renal mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been described in the literature. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in percutaneous renal parenchymal biopsy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core needle biopsy with coaxial method | Experimental | Device: coaxial renal biopsyThe patients undergo renal biopsy with a coaxial Tru-Cut needle |
| Core needle biopsy with noncoaxial method | Experimental | Device: noncoaxial renal biopsyThe patients undergo renal biopsy with a noncoaxial Tru-Cut needle |
Who may qualify
- Ages
- 10 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- impaired renal function
- proteinuria
- hematuria
Key exclusion criteria (5 listed)
- renal hydronephrosis
- chronic renal failure
- a history of renal cell carcinoma
- suspicious renal mass
- uncorrectable coagulopathy
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 |
|---|---|---|
| coaxial renal biopsyAlso: 18-gauge semiautomatic biopsy system with the coaxial needle; Tasuku Laboratory, Tochigi, JapanIn this method, a larger introducing needle is used for the puncture. The introducing needle is advanced just to the outer cortex of the kidney, and the needle angle is adjusted so that the needle pathway became mostly in the renal cortex, then the biopsy needle is inserted throughout the introducing needle and at least 4 cores are obtained. In this technique, the skin surface is punctured only once during the procedure. | Device | Core needle biopsy with coaxial method |
| noncoaxial renal biopsyAlso: 18-gauge semiautomatic biopsy system without coaxial needle; Tasuku Laboratory, Tochigi, JapanIn this method, introducing needle is not used. Biopsy needle punctures the skin surface and the needle is advanced to about 10-15 mm into the renal cortex, and tissue sampling is done. After each sampling, the needle is removed and then for the next biopsy, the whole procedure is repeated until four cores being taken. | Device | Core needle biopsy with noncoaxial method |
Primary outcome
complication ratio
Time frame: within 48 hours after the procedure
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 2 May 2016.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coaxial renal biopsy and noncoaxial renal biopsy in people with Image-guided Biopsy and Complications, run by Modarres Hospital at 1 site in Iran.
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 5 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 2 May 2016. 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 Iran. 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?
complication ratio (time frame: within 48 hours after the procedure). 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 2 May 2016.