Cryobiopsy of the kidneys (including renal pelvis): clinical in vivo evaluation in the human upper urinary tract.

Not Applicable

Conditions: C65
C66
Malignant neoplasm of renal pelvis
Malignant neoplasm of ureter

Registration Number: DRKS00025620

Lead Sponsor: Abteilung Urologie und Kinderurologie, Universitätsklinikum Ulm, Kliniken am oberen Eselsberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 35

Inclusion Criteria

Patients with the image morphological correlate of a renal pelvic tumor in the imaging diagnosis < 2 months before biopsy collection (means computed tomography or alternatively magnetic resonance imaging).
o Suspected tumor lesions > 5 mm on diagnostic imaging will undergo endoscopic specimen biopsy to confirm the diagnosis as part of the preoperative diagnostic workup.
- Signed consent form

Exclusion Criteria

- Patients with single kidney
- Patients with pronounced bleeding tendency
- Patients with transplant kidneys
- Patients with high-grade chronic renal failure or functional single kidney
- Patients with acute urinary tract infection
- Patients who are younger than 18 years
- Patients who are pregnant
- Patients who are not capable of giving their own consent
- Patients who are already participating in another study

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The diagnosis can be made on tissue taken from the human upper urinary tract by cryobiopsy in vivo.

Secondary Outcome Measures

Name	Time	Method
- Feasibility of cryobiopsy in vivo (with number of attempts until a biopsy specimen was macroscopically obtained).<br>- Increase in diagnostic rate using cryobiopsy with the cryoprobe (CB11) compared to the standard biopsy procedure for human urothelial tumors.<br>- Assess the safety of cryobiopsy sampling with the cryoprobe (CB11).<br>o Bleeding (recording by severity).<br>o Other complications (perforation, injury to the renal pelvic caliceal system, occurrence of infections).<br>- Recording of histo-pathological quality and quantity of CB11 (largest cross-sectional area, percentage of artifacts, histo-morpho score/histo-pathological assessability of tissue, representativeness).<br>o And comparison to the respective standard biopsy procedure.<br>Renal pelvis: standard biopsy forceps (FBx) and dormia basket.<br>- Acquisition of histo-pathological assessment of total tissue (biopsy removal/organ removal) in relation to diagnostic rate.