An interventional study of Nebulized Glubran 2-Assisted Tubeless PCNL and Conventional PCNL With Nephrostomy Tube in Kidney Calculi and Nephrolithiasis, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 100 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo percutaneous nephrolithotomy followed by tubeless closure of the percutaneous access tract. After stone removal and confirmation of no significant collecting-system injury, 1 mL of Glubran 2 will be delivered into the tract using a special nebulizing applicator under endoscopic and fluoroscopic guidance. The tract will be temporarily occluded using the balloon of a 16 Fr Foley catheter. No nephrostomy tube will be placed. A 6 Fr double-J ureteral stent may be inserted when clinically indicated.
Procedure: Nebulized Glubran 2-Assisted Tubeless PCNL
Participants will undergo conventional percutaneous nephrolithotomy. After stone removal, a 24 Fr Nelaton tube will be placed as a nephrostomy tube for postoperative drainage. The nephrostomy tube is planned to be removed after approximately 24 hours, according to the participant's clinical condition. A 6 Fr double-J ureteral stent may be inserted when clinically indicated.
Procedure: Conventional PCNL With Nephrostomy Tube
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.
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.
Postoperative Pain Intensity
Postoperative pain will be assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be compared between the nebulized Glubran 2-assisted tubeless PCNL group and the conventional PCNL group.
Time frame: Within the first 24 hours after surgery
Stone-Free Rate
The proportion of participants with no clinically significant residual renal stones on postoperative imaging will be compared between the two study groups.
Time frame: At 24 hours after surgery
Postoperative Hemoglobin Change
The change in hemoglobin concentration will be calculated as the preoperative hemoglobin value minus the postoperative hemoglobin value, measured in g/dL.
Time frame: From baseline before surgery to 24 hours after surgery
Blood Transfusion Requirement
The proportion of participants requiring packed red blood cell transfusion after the procedure.
Time frame: From the end of surgery through 24 hours after surgery
Urinary Leakage
The proportion of participants developing clinically evident urine leakage from the percutaneous access site.
Time frame: From the end of surgery through 48 hours after surgery
Length of Hospital Stay
The proportion of participants experiencing postoperative complications, including bleeding, fever, urinary leakage, infection, or need for an additional intervention.
Time frame: From the end of surgery through 30 days after surgery
Intraoperative Blood Loss
Estimated blood loss during the surgical procedure will be recorded in milliliters.
Time frame: Intraoperatively
Fluoroscopy Exposure Time
The cumulative duration of fluoroscopic exposure will be recorded in seconds.
Time frame: Intraoperatively
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 5 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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