Kidney CalculiNCT07749807
Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL
A study testing Nebulized Glubran 2-Assisted Tubeless PCNL and Conventional PCNL With Nephrostomy Tube in people with Kidney Calculi and Nephrolithiasis, run by Benha University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Calculi, Nephrolithiasis
- What is being tested?
- Nebulized Glubran 2-Assisted Tubeless PCNL and Conventional PCNL With Nephrostomy Tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active urinary tract infection.
- Renal stones in an anomalous kidney.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus.
- Uncorrected coagulopathy.
- Clinically significant arrhythmia.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Saad A Salama, MD, 01063006039 ext. +2, saad.ali@fmed.bu.edu.eg
About this study
Official title: A Novel Technique in Tubeless Percutaneous Nephrolithotomy Using Nebulized Glubran 2 Versus Conventional Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Study
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.
- Conditions
- Kidney Calculi, Nephrolithiasis
- Being tested
- Nebulized Glubran 2-Assisted Tubeless PCNL, Conventional PCNL With Nephrostomy Tube
- Keywords
- Percutaneous nephrolithotomy, Tubeless percutaneous nephrolithotomy, Conventional percutaneous nephrolithotomy, Glubran 2, Cyanoacrylate tissue adhesive, Percutaneous tract sealing, Nephrostomy tube, Kidney stones, Renal calculi, Stone-free rate, Postoperative pain, Postoperative bleeding
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Pain, Postoperative, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized Glubran 2-Assisted Tubeless PCNLProcedure or surgery
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.
Conventional PCNL With Nephrostomy TubeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Glubran 2-Assisted Tubeless PCNL | Experimental | 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. Receives: Procedure: Nebulized Glubran 2-Assisted Tubeless PCNL |
| Conventional PCNL With Nephrostomy Tube | Active comparator | 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. Receives: Procedure: Conventional PCNL With Nephrostomy Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 24 hours after surgery
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperatively
Fluoroscopy Exposure Time
The cumulative duration of fluoroscopic exposure will be recorded in seconds.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel to either nebulized Glubran 2-assisted tubeless percutaneous nephrolithotomy or conventional percutaneous nephrolithotomy with nephrostomy tube placement.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad ali saad salama, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749807
- Sponsor's protocol ID
- RC.9.1.2026
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique in Tubeless Percutaneous Nephrolithotomy Using Nebulized Glubran 2 Versus Conventional Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07749807
- Acronym / sponsor ID
- RC.9.1.2026
- Conditions
- Kidney Calculi, Nephrolithiasis
- Keywords
- Percutaneous nephrolithotomy, Tubeless percutaneous nephrolithotomy, Conventional percutaneous nephrolithotomy, Glubran 2, Cyanoacrylate tissue adhesive, Percutaneous tract sealing, Nephrostomy tube, Kidney stones
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in parallel to either nebulized Glubran 2-assisted tubeless percutaneous nephrolithotomy or conventional percutaneous nephrolithotomy with nephrostomy tube placement.
| Arm | Type | Receives |
|---|---|---|
| Nebulized Glubran 2-Assisted Tubeless PCNL | Experimental | Procedure: Nebulized Glubran 2-Assisted Tubeless PCNLParticipants 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 comparator | Procedure: Conventional PCNL With Nephrostomy TubeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Active urinary tract infection.
- Renal stones in an anomalous kidney.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus.
- Uncorrected coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulized Glubran 2-Assisted Tubeless PCNLFollowing 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 or surgery | Nebulized Glubran 2-Assisted Tubeless PCNL |
| Conventional PCNL With Nephrostomy TubeFollowing 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. | Procedure or surgery | Conventional PCNL With Nephrostomy Tube |
Primary outcome
Postoperative Pain Intensity
Time frame: Within the first 24 hours after surgery
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulized Glubran 2-Assisted Tubeless PCNL and Conventional PCNL With Nephrostomy Tube in people with Kidney Calculi and Nephrolithiasis, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saad A Salama, MD (01063006039 ext. +2, saad.ali@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Within the first 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.