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

September 28, 2026 updated by: Ahmed EssamEldin Ali Mahmoud, Assiut University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: Ultrasound-guided percutaneous nephrostomy

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Technical Success Rate of Ultrasound-Guided Percutaneous Nephrostomy
Time Frame: 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).
24 hours post-procedure
Incidence of Procedure-Related Complications
Time Frame: 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).
2 weeks post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • US-Guided PCN in Oncology

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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