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NCT Number: NCT07749807

Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL

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.

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Key information

Conditions

Kidney Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Hemorrhage Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location contact

Saad A Salama, MD

CONTACT

[email protected]

01063006039 ext. +2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nebulized Glubran 2-Assisted Tubeless PCNL

Procedure

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 Tube

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. Stone-Free Rate

    Time frame: At 24 hours after surgery

    The proportion of participants with no clinically significant residual renal stones on postoperative imaging will be compared between the two study groups.

  2. Postoperative Hemoglobin Change

    Time frame: From baseline before surgery to 24 hours after surgery

    The change in hemoglobin concentration will be calculated as the preoperative hemoglobin value minus the postoperative hemoglobin value, measured in g/dL.

  3. Blood Transfusion Requirement

    Time frame: From the end of surgery through 24 hours after surgery

    The proportion of participants requiring packed red blood cell transfusion after the procedure.

  4. Urinary Leakage

    Time frame: From the end of surgery through 48 hours after surgery

    The proportion of participants developing clinically evident urine leakage from the percutaneous access site.

  5. Length of Hospital Stay

    Time frame: From the end of surgery through 30 days after surgery

    The proportion of participants experiencing postoperative complications, including bleeding, fever, urinary leakage, infection, or need for an additional intervention.

  6. Intraoperative Blood Loss

    Time frame: Intraoperatively

    Estimated blood loss during the surgical procedure will be recorded in milliliters.

  7. Fluoroscopy Exposure Time

    Time frame: Intraoperatively

    The cumulative duration of fluoroscopic exposure will be recorded in seconds.

Study contacts

Contact information is provided by the study sponsor or research team.

Saad A Salama, MD

CONTACT

[email protected]

01063006039 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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