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Completed

NCT Number: NCT02758535

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.

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Key information

Age range

10 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Rasht, Gilan Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 18-gauge semiautomatic biopsy system with the coaxial needle; Tasuku Laboratory, Tochigi, Japan

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.

Other names: 18-gauge semiautomatic biopsy system without coaxial needle; Tasuku Laboratory, Tochigi, Japan

Primary outcomes

  1. complication ratio

    Time frame: within 48 hours after the procedure

Sponsors and collaborators

Lead sponsor

Modarres Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
May 2, 2016
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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