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NCT Number: NCT06889051

Comparison of Flexible & Navigable Suction Ureteral Access Sheath vs. Antegrade Suction in Retrograde Flexible Ureteroscopy for Lower Calyceal Stones

This randomized controlled trial aims to compare the efficacy and safety of two suction techniques during retrograde flexible ureteroscopy (FURS) for lower calyceal renal stones measuring 1.5-2 cm. The study evaluates Flexible & Navigable Suction Ureteral Access Sheath (FANS) versus Antegrade Suction (via percutaneous access) in improving stone-free rates (SFR), reducing operative time, and minimizing complications such as bleeding, ureteral injury, and infection. A total of 120 adult patients will be randomized into two groups, undergoing either flexible ureteroscopy (FURS) with Flexible & Navigable Suction Ureteral Access Sheath (FANS) or flexible ureteroscopy (FURS) with antegrade suction, at Banha University Faculty of Medicine.

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Key information

Conditions

Nephrolithiasis Endourology Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥18 years old)
  • Patients diagnosed with renal stones (1.5-2 cm) confirmed by non-contrast computed tomography (NCCT)
  • Patients undergoing flexible ureteroscopy (FURS) as the primary treatment approach
  • Patients with no active urinary tract infection (UTI) at baseline
  • Patients who provide written informed consent

Exclusion criteria

  • Patients with anatomical anomalies (e.g., horseshoe kidney, PUJ obstruction)
  • Patients with a single functioning kidney
  • Pregnant women
  • Patients with a history of urological malignancy
  • Patients with active bleeding disorders or those on anticoagulant therapy that cannot be safely discontinued
  • Patients at high risk for anesthesia

Treatment and study plan

Flexible & Navigable Suction Ureteral Access Sheath (FANS)

Procedure

The Flexible & Navigable Suction Ureteral Access Sheath (FANS) is used during retrograde flexible ureteroscopy (FURS) for renal stones (1.5-2 cm). It allows continuous active suctioning, improving stone fragment evacuation, reducing operative time, lowering intrarenal pressure, and optimizing stone-free rates (SFR). The procedure involves inserting the Navigator 10F, 55 cm YIGAOMED FANS over a guidewire, followed by flexible ureteroscopy with PUSEN® 9.2 Fr ureteroscope and laser lithotripsy using Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W).

Antegrade Suction via Percutaneous Nephrostomy

Procedure

This technique involves antegrade suction from the kidney during flexible ureteroscopy (FURS) without the use of a ureteral access sheath. A percutaneous nephrostomy (PCN) tract is created using an 18G needle, and a 6F renal dilator is placed and fixed to the skin, allowing for direct suctioning from the collecting system. Following this, retrograde flexible ureteroscopy (FURS) is performed using the PUSEN® 9.2 Fr ureteroscope and Holmium Laser (JenaSurgical® MultiPulse HoPLUS™ 150W) for stone fragmentation. This technique aims to improve stone clearance while minimizing ureteral trauma associated with access sheaths.

Primary outcomes

  1. Stone-Free Rate (SFR)

    Time frame: 1 Month Postoperative

    The stone-free rate (SFR) will be assessed one month postoperatively using non-contrast computed tomography (NCCT) to determine the presence or absence of residual stone fragments ≥4 mm. A higher SFR indicates better effectiveness of the intervention.

Secondary outcomes

  1. Operative Time

    Time frame: During Surgery

    The total operative time will be recorded from the initial endoscopic access to procedure completion. This includes access sheath insertion, ureteroscopy, lithotripsy, and final stone evacuation. A shorter operative time is indicative of a more efficient technique.

  2. Intraoperative Bleeding Requiring Intervention

    Time frame: During Surgery

    The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.

  3. Ureteral Injury

    Time frame: During Surgery

    The incidence of ureteral injuries, including mucosal damage, perforation, or full-thickness injury, will be documented. The severity will be graded based on endoscopic findings and clinical impact.

  4. Postoperative Hematuria

    Time frame: Within 7 Days Postoperative

    The presence of postoperative hematuria (macroscopic bleeding) will be assessed. It will be classified as mild (self-limited), moderate (requiring irrigation), or severe (requiring intervention such as transfusion or embolization).

  5. Postoperative Urosepsis

    Time frame: Within 7 Days Postoperative

    The incidence of postoperative urosepsis, defined as systemic inflammatory response syndrome (SIRS) with a positive urine culture and clinical deterioration requiring IV antibiotics or ICU admission, will be recorded.

Study contacts

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

Tamer Diab, MD

CONTACT

[email protected]

01003583264 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Comparison Study Between Using Retrograde Flexible Ureteroscopy With Flexible & Navigable Suction Ureteral Access Sheath Versus Retrograde Flexible Ureteroscopy With Antegrade Suction in Lower Calyceal Stone: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

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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