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CompletedNCT02758535Updated May 2, 2016

Renal Parenchymal Core Needle Biopsy

An interventional study of coaxial renal biopsy and noncoaxial renal biopsy in Image-guided Biopsy, Complications and Kidney Glomerulus, sponsored by Modarres Hospital. Completed at 1 site in Iran, Islamic Republic of. Open to male participants aged 10 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Modarres Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Randomized
Ages
10 Years to 90 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Image-guided Biopsy
  • Complications
  • Kidney Glomerulus
03

In context

Lead sponsor

Modarres Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • impaired renal function
  • proteinuria
  • hematuria

Exclusion criteria

Exclusion Criteria:

  • renal hydronephrosis
  • chronic renal failure
  • a history of renal cell carcinoma
  • suspicious renal mass
  • uncorrectable coagulopathy
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
166 participants (actual)

Study arms

  • Experimental
    Core needle biopsy with coaxial method

    The patients undergo renal biopsy with a coaxial Tru-Cut needle

    Device: coaxial renal biopsy

  • Experimental
    Core needle biopsy with noncoaxial method

    The patients undergo renal biopsy with a noncoaxial Tru-Cut needle

    Device: noncoaxial renal biopsy

Interventions

  • Devicecoaxial renal biopsy

    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.

    Also known as: 18-gauge semiautomatic biopsy system with the coaxial needle; Tasuku Laboratory, Tochigi, Japan

  • Devicenoncoaxial renal biopsy

    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.

    Also known as: 18-gauge semiautomatic biopsy system without coaxial needle; Tasuku Laboratory, Tochigi, Japan

06

What researchers measure

Primary outcomes

  1. complication ratio

    Time frame: within 48 hours after the procedure

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Study locations

1 site
  • Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences
    Rasht, Guilan, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02758535
Lead sponsor
Modarres Hospital
Responsible party
Sponsor
First posted
May 2, 2016
Start date
Mar 2015
Primary completion
Jun 2015
Completion
Mar 2016
Last update
May 2, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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