Tract Closure in PCNL
Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
1 other identifier
interventional
92
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 25, 2026
June 1, 2026
1.8 years
May 28, 2026
June 21, 2026
Conditions
Outcome Measures
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.
Baseline and Post-operative Day 0
Secondary Outcomes (4)
Change in Hemoglobin from baseline to Post-operative Day 10
Baseline and Post-operative Day 10
Ureteroscopic tract bleeding score
Post-operative Day 0
Proportion of participants undergoing stent placement
Post-operative Day 0
Number of bleeding related events
Post-operative Day 30
Study Arms (4)
Balloon Tamponade with no hemostatic agent
ACTIVE COMPARATORBalloon tamponade alone with no hemostatic agent acts as a control.
Balloon Tamponade with Floseal
EXPERIMENTALBalloon tamponade with Floseal as hemostatic agent.
Balloon Tamponade with Surgicel
EXPERIMENTALBalloon Tamponade with Surgicel as hemostatic agent.
Balloon Tamponade with Surgiflo
EXPERIMENTALBalloon tamponade with Surgilfo as hemostatic agent.
Interventions
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® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.
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 is utilized to manage tract related bleeding.
Eligibility Criteria
You may qualify if:
- At least one stone ≥ 1.2cm
- Scheduled to undergo planned PCNL
- Age ≥ 18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai West
New York, New York, 10019, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mantu Gupta, MD
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Urology
Study Record Dates
First Submitted
May 28, 2026
First Posted
June 25, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 25, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
To protect participant privacy