Renal Parenchymal Core Needle Biopsy

NCT02758535 | Completed

• 1 other identifier: Renal Parenchymal Biopsy
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Image-guided Biopsy; Complications; Kidney Glomerulus

Outcome Measures

Primary Outcomes (1)

• complication ratio

  within 48 hours after the procedure

Study Arms (2)

Core needle biopsy with coaxial method

EXPERIMENTAL

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

Device: coaxial renal biopsy

Core needle biopsy with noncoaxial method

EXPERIMENTAL

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

Device: noncoaxial renal biopsy

Interventions

coaxial renal biopsy DEVICE

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

Core needle biopsy with coaxial method

noncoaxial renal biopsy DEVICE

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

Core needle biopsy with noncoaxial method

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• impaired renal function
• proteinuria
• hematuria

You may not qualify if:

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

Sponsors & Collaborators

• Modarres Hospital: lead

Study Sites (1)

Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences

Rasht, Gilan Province, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 2, 2016
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)