Safety and Efficacy of Ultrasound-Guided Percutaneous Nephrostomy in Oncology Patients

NCT07855666 — Not applicable, Not yet recruiting, 40 participants, Assiut University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07855666
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	40 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Obstructive Uropathy, Hydronephrosis, Ureteral Obstruction, Acute Kidney Injury, Neoplasms
Interventions	Ultrasound-guided percutaneous nephrostomy (Procedure)
Dates	start 2026-11-01 (estimated), primary completion 2027-11-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-10-02, last updated 2026-10-02

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Ultrasound-Guided Percutaneous Nephrostomy	Experimental	Procedure: Ultrasound-guided percutaneous nephrostomy	Participants with known or suspected primary malignancy presenting with ureteric obstruction undergo ultrasound-guided percutaneous nephrostomy (PCN) using the standard Seldinger technique. Under local anesthesia and real-time ultrasound guidance, percutaneous access to the collecting system (targeting a lower pole posterior calyx) is achieved using an 18-gauge puncture needle (or 21/22-gauge Chiba needle). A 0.035-inch or 0.038-inch J-tip guidewire is advanced into the renal pelvis, followed by serial fascial dilation and placement of an 8Fr locking pigtail nephrostomy catheter connected to external gravity drainage.

Ultrasound-guided percutaneous nephrostomy (Procedure): Ultrasound-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.

+Outcome measures

Primary outcomes

Technical Success Rate of Ultrasound-Guided Percutaneous Nephrostomy [24 hours post-procedure]: 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).
Incidence of Procedure-Related Complications [2 weeks post-procedure]: 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).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.