Menu
Not yet recruiting NCT07749807

Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL

No phase Interventional Kidney Calculi Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nebulized Glubran 2-Assisted Tubeless PCNL, Conventional PCNL With Nephrostomy Tube.
Who it may be relevant to
Registry conditions: Kidney Calculi, Nephrolithiasis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Novel Technique in Tubeless Percutaneous Nephrolithotomy Using Nebulized Glubran 2 Versus Conventional Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Study

Overview

This prospective randomized controlled study will compare two techniques used after percutaneous nephrolithotomy, a procedure for removing kidney stones. Participants with renal stones measuring 2-3 cm will be randomly assigned to either tubeless percutaneous nephrolithotomy with nebulized Glubran 2 used to seal the access tract or conventional percutaneous nephrolithotomy with placement of a nephrostomy tube. The study will evaluate whether the Glubran 2-assisted tubeless technique is safe and effective and whether it can reduce postoperative pain, bleeding, hospital stay, urine leakage, and other complications while maintaining a satisfactory stone-free rate.

Interventions

  • Procedure Nebulized Glubran 2-Assisted Tubeless PCNL
    Following stone removal by percutaneous nephrolithotomy, 1 mL of Glubran 2 will be nebulized into the percutaneous access tract using a special applicator under endoscopic and fluoroscopic guidance. The tract will be temporarily occluded using a 16 Fr Foley catheter balloon, and no nephrostomy tube will be placed.
  • Procedure Conventional PCNL With Nephrostomy Tube
    Following stone removal by percutaneous nephrolithotomy, a 24 Fr Nelaton tube will be placed as a nephrostomy tube for postoperative drainage and will generally be removed after approximately 24 hours according to the participant's clinical condition.

Primary outcome measures

  • Postoperative Pain Intensity [Time frame: Within the first 24 hours after surgery]
Secondary outcome measures (7)
  • Stone-Free Rate [Time frame: At 24 hours after surgery]
  • Postoperative Hemoglobin Change [Time frame: From baseline before surgery to 24 hours after surgery]
  • Blood Transfusion Requirement [Time frame: From the end of surgery through 24 hours after surgery]
  • Urinary Leakage [Time frame: From the end of surgery through 48 hours after surgery]
  • Length of Hospital Stay [Time frame: From the end of surgery through 30 days after surgery]
  • Intraoperative Blood Loss [Time frame: Intraoperatively]
  • Fluoroscopy Exposure Time [Time frame: Intraoperatively]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older.
  • Single or multiple renal stones measuring 2-3 cm.
  • Renal stones located in an anatomical position suitable for percutaneous nephrolithotomy.
  • Participant considered suitable for PCNL under general anesthesia.
  • Ability and willingness to provide written informed consent.

Exclusion criteria

  • Active urinary tract infection.
  • Renal stones in an anomalous kidney.
  • Uncontrolled hypertension.
  • Uncontrolled diabetes mellitus.
  • Uncorrected coagulopathy.
  • Clinically significant arrhythmia.
  • Distal ureteric obstruction.
  • Fixed hip joints preventing appropriate operative positioning.
  • Previous renal surgery.
  • Requirement for more than one percutaneous puncture.
  • Pelvicalyceal system perforation during the procedure.
  • Excessive intraoperative bleeding.
  • Any intraoperative finding requiring nephrostomy tube placement for safety.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Benha University Hospital — Banhā

Identifiers

NCT: NCT07749807 · RC.9.1.2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗