Tract Closure in PCNL

ID#: NCT07668817

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: July 01, 2026

End Date: June 01, 2028

Contact Information:
Mantu Gupta, MD
212-241-1272
Blair Gallante, MPH
212-241-1272
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.
Eligibility:

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
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