Safety and Efficacy of Ultrasound-Guided Percutaneous Nephrostomy in Oncology Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Obstructive uropathy is a serious complication frequently seen in cancer patients, occurring when urine flow from the kidneys is blocked by tumor compression, invasion, or benign etiologies such as radiation-induced strictures and stones. If left untreated, this blockage leads to hydronephrosis, acute kidney impairment, and interruptions in cancer therapy. When internal ureteral stenting fails or is not possible, percutaneous nephrostomy (PCN), which involves inserting a small drainage tube through the back directly into the renal collecting system, is required to decompress the kidney and preserve renal function.
Traditionally, PCN is performed under fluoroscopy, exposing patients and healthcare staff to ionizing radiation. Ultrasound guidance provides continuous real-time visualization of the renal structures while completely eliminating radiation hazards.
The primary purpose of this prospective interventional study is to evaluate the technical success, safety, and complication rates of ultrasound-guided percutaneous nephrostomy in oncology patients presenting with urinary tract obstruction.
Participants in this study undergo ultrasound-guided PCN under local anesthesia using the standard Seldinger technique to place an 8Fr pigtail drainage catheter. The study evaluates the technical success rate of the procedure, procedural and post-procedural complications (such as bleeding or sepsis), recovery of kidney function measured by changes in serum creatinine levels, and hospital length of stay.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with known or suspected primary malignancy.
Confirmed ureteric obstruction on diagnostic imaging (ultrasound or CT), whether due to malignant etiology (e.g., extrinsic tumor compression or direct invasion) or benign etiology (e.g., calculi, radiation-induced stricture, or iatrogenic injury).
Clinical or biochemical evidence of acute renal impairment or symptomatic hydronephrosis necessitating urgent or elective decompression.
Disqualifiers
Patients who refuse the intervention or withdraw consent.
Patients undergoing simultaneous retrograde or antegrade ureteric stent placement during the same procedure.
Patients with uncorrectable coagulopathy (abnormal PT/INR or severe thrombocytopenia).
Strict medical contraindications to percutaneous interventions.
Trial design
Design model
Single group
Treatments tested in this trial
Ultrasound-guided percutaneous nephrostomy
Procedure/SurgeryUltrasound-guided placement of a percutaneous nephrostomy (PCN) catheter using the standard Seldinger technique. Under local anesthesia (1% or 2% lidocaine) and continuous real-time ultrasound visualization without fluoroscopy, access to the dilated pelvicalyceal system is achieved via posterolateral puncture targeting a lower pole posterior calyx using an 18-gauge needle (or 21/22-gauge Chiba needle). A 0.035-inch or 0.038-inch J-tip guidewire is advanced and coiled within the renal pelvis. The tract is serially dilated over the guidewire using sequential fascial dilators, followed by insertion of an 8Fr locking pigtail nephrostomy catheter into the renal collecting system. Proper intrapelvic positioning is confirmed sonographically and via free drainage of urine. The catheter is locked, sutured to the skin with non-absorbable sutures, dressed sterilely, and connected to an external gravity drainage bag.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Ultrasound-Guided Percutaneous NephrostomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Technical Success Rate of Ultrasound-Guided Percutaneous Nephrostomy
Percentage of procedures resulting in successful puncture and placement of an 8Fr locking pigtail nephrostomy catheter into the renal pelvicalyceal system using ultrasound guidance alone, confirmed by free drainage of urine and post-procedure imaging (ultrasound or KUB radiograph).
Time frame
24 hours post-procedure2
Incidence of Procedure-Related Complications
Percentage of participants experiencing procedural or post-procedural complications, including major adverse events (severe retroperitoneal hemorrhage, urosepsis) and minor adverse events (persistent hematuria, tube displacement, or local puncture site infection).
Time frame
2 weeks post-procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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