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NCT Number: NCT07668817

Tract Closure in PCNL

This is a prospective, randomized controlled trial evaluating the effect of a hemostatic agent on tract-related bleeding during percutaneous nephrolithotomy (PCNL). Patients undergoing standardized PCNL will be randomized to receive either application of a hemostatic agent or no agent during tract closure, following uniform balloon occlusion, complete aspiration, and irrigation-free endoscopic assessment. The researchers hypothesize that adjunctive hemostatic agent use reduces perioperative hemoglobin decline compared with balloon tamponade alone and improves tract-related hemostasis outcomes.

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Key information

Conditions

Nephrolithiasis 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

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least one stone ≥ 1.2cm
  • Scheduled to undergo planned PCNL
  • Age ≥ 18 years

Exclusion criteria

  • Unable to provide informed consent
  • Pre-existing nephrostomy tube
  • Multi access cases
  • Stone in calyceal diverticulum/hydrocalyx
  • Preoperatively planned overnight admission for any reason
  • Infundibular stenosis
  • Coagulation disorders
  • Other significant anatomic abnormalities

Treatment and study plan

Floseal

Device

Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.

Surgicel

Device

SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.

Surgiflo

Device

SURGIFLO® Hemostatic Matrix is an Ethicon porcine gelatin-based, flowable hemostatic agent used to stop bleeding during surgery, typically reaching hemostasis within seconds to minutes.

Balloon Tamponade

Procedure

Balloon tamponade is utilized to manage tract related bleeding.

Primary outcomes

  1. Change in hemoglobin from baseline to PACU

    Time frame: Baseline and Post-operative Day 0

    Change in Hemoglobin from preoperative baseline CBC to PACU CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells.

Secondary outcomes

  1. Change in Hemoglobin from baseline to Post-operative Day 10

    Time frame: Baseline and Post-operative Day 10

    Change in Hemoglobin from preoperative baseline CBC to postoperative day 10 CBC. A hemoglobin test measures the levels of hemoglobin in the blood. Hemoglobin is an iron-rich protein in the red blood cells. It carries oxygen from the lungs to the rest of the body. Cells need oxygen to grow, reproduce, and make energy to function. Hemoglobin levels provide information about the health of red blood cells.

  2. Ureteroscopic tract bleeding score

    Time frame: Post-operative Day 0

    Ureteroscopic tract bleeding score provides a direct, anatomically specific measure of tract hemostasis that complements laboratory-based bleeding outcomes. Bleeding score is based on a 0-3 ordinal scale. 0 equals no visible tract bleeding whereas 3 equals active tract bleeding that significantly impairs visualization. Higher score indicates more bleeding and poor health outcome.

  3. Proportion of participants undergoing stent placement

    Time frame: Post-operative Day 0

    Proportion of participants undergoing stent placement at procedure completion. Drainage decisions reflect surgeon assessment of tract bleeding and represent a clinically meaningful downstream consequence of hemostasis. This is measured as a binary patient-level outcome (stent placed: yes/no)

  4. Number of bleeding related events

    Time frame: Post-operative Day 30

    Number of bleeding related events within 30 days ensures adjunctive hemostatic agent use does not introduce excess bleeding-related morbidity.

Study contacts

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

Blair Gallante, MPH

CONTACT

[email protected]

212-241-1272

Mantu Gupta, MD

CONTACT

[email protected]

212-241-1272

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 25, 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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