Renal Parenchymal Core Needle Biopsy

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 Overview

• Status: Completed
• Conditions: Complications; Image-guided Biopsy; Kidney Glomerulus
• Intervention / Treatment: Device: coaxial renal biopsy; Device: noncoaxial renal biopsy

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• impaired renal function
• proteinuria
• hematuria

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core needle biopsy with coaxial method; The patients undergo renal biopsy with a coaxial Tru-Cut needle	Device: coaxial 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.; Other Names: 18-gauge semiautomatic biopsy system with the coaxial needle; Tasuku Laboratory, Tochigi, Japan
Experimental: Core needle biopsy with noncoaxial method; The patients undergo renal biopsy with a noncoaxial Tru-Cut needle	Device: noncoaxial 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.; Other Names: 18-gauge semiautomatic biopsy system without coaxial needle; Tasuku Laboratory, Tochigi, Japan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
complication ratio	within 48 hours after the procedure

Collaborators and Investigators

• Sponsor: Modarres Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 29, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Renal Parenchymal Biopsy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No