Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL
A Novel Technique in Tubeless Percutaneous Nephrolithotomy Using Nebulized Glubran 2 Versus Conventional Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Study
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2026
CompletedFirst Posted
Study publicly available on registry
August 6, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
Study Completion
Last participant's last visit for all outcomes
February 1, 2027
August 6, 2026
August 1, 2026
5 months
August 3, 2026
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Within the first 24 hours after surgery
Secondary Outcomes (7)
Stone-Free Rate
At 24 hours after surgery
Postoperative Hemoglobin Change
From baseline before surgery to 24 hours after surgery
Blood Transfusion Requirement
From the end of surgery through 24 hours after surgery
Urinary Leakage
From the end of surgery through 48 hours after surgery
Length of Hospital Stay
From the end of surgery through 30 days after surgery
- +2 more secondary outcomes
Study Arms (2)
Nebulized Glubran 2-Assisted Tubeless PCNL
EXPERIMENTALParticipants 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.
Conventional PCNL With Nephrostomy Tube
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Benha University Hospital
Banhā, Qalyubia Governorate, 13511, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Urology
Study Record Dates
First Submitted
August 3, 2026
First Posted
August 6, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
August 6, 2026
Record last verified: 2026-08