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Tract Closure in PCNL

ConditionNephrolithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least one stone ≥ 1.2cm

Scheduled to undergo planned PCNL

Age ≥ 18 years

Disqualifiers

Unable to provide informed consent

Pre-existing nephrostomy tube

Multi access cases

Stone in calyceal diverticulum/hydrocalyx

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Balloon tamponade is utilized to manage tract related bleeding.

Treatment groups

92 Participants
are divided into 4 treatment groups
Group A: Balloon Tamponade with no hemostatic agentActive comparator 1 intervention
Group B: Balloon Tamponade with FlosealExperimental treatment 2 interventions
Group C: Balloon Tamponade with SurgicelExperimental treatment 2 interventions
Group D: Balloon Tamponade with SurgifloExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in hemoglobin from baseline to PACU

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.

Time frame
Baseline and Post-operative Day 0

Secondary outcomes

1

Change in Hemoglobin from baseline to 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.

Time frame
Baseline and Post-operative Day 10
2

Ureteroscopic tract bleeding score

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.

Time frame
Post-operative Day 0
3

Proportion of participants undergoing stent placement

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)

Time frame
Post-operative Day 0
4

Number of bleeding related events

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

Time frame
Post-operative Day 30

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

Source ClinicalTrials.gov
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