Renal Parenchymal Core Needle Biopsy

Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758535
• Other study ID #: Renal Parenchymal Biopsy
• Status: Completed
• Phase: N/A
• First received: April 29, 2016
• Last updated: April 29, 2016
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Modarres Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: March 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Complications
• Image-guided Biopsy
• Kidney Glomerulus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences	Rasht	Guilan

Sponsors (1)

Lead Sponsor	Collaborator
Modarres Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication ratio		within 48 hours after the procedure	No